Data / Medical devices / United States / Diagnostic Automation/ Cortez Diagnostics Inc,.

Diagnostic Automation/ Cortez Diagnostics Inc,.: FDA-registered device maker in Woodland Hills, CA, United States, 143 510(k) clearances

Name: Diagnostic Automation/ Cortez Diagnostics Inc,. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Diagnostic Automation/ Cortez Diagnostics Inc,. is registered with the FDA (registration 2029372) in Woodland Hills, CA, United States. It lists 193 device types. The FDA files 143 510(k) clearances under its listings, the newest dated July 3, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Diagnostic Automation/ Cortez Diagnostics Inc,.

FDA registration number: 2029372
FEI number: 1000306617
Address: 21250 Califa St Suite 102 and 116, Woodland Hills, CA, United States, 91367
Owner or operator: Diagnostic Automation /Cortez Diagnostics Inc. (9011974)
Roles: Manufacturer, Manufacturer for export, Remanufacturer, Repackager or relabeler
First device listed: April 17, 2008
Registered through: 2026
Brand names listed: AFP Rapid Test, AMA, ANA, ANCA Screen, ASA, ASO Latex, AccuDiag Chlamydia, AccuDiag FSH ELISA and more

Devices it lists

Device	Product code	Class	Role	Source
Albumin, Rhodamine, Antigen, Antiserum, Control	DFJ	2	Manufacturer	accessdata.fda.gov
Amplifier And Signal Conditioner, Biopotential	DRR	2	Manufacturer	accessdata.fda.gov
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	LRM	2	Manufacturer	accessdata.fda.gov
Anti-Human Globulin, Fta-Abs Test	GMS	2	Manufacturer	accessdata.fda.gov
Antibodies, Gliadin	MST	2	Manufacturer	accessdata.fda.gov
Antibody Igm, If, Epstein-Barr Virus	LJN	1	Manufacturer	accessdata.fda.gov
Antibody Igm,If, Cytomegalovirus Virus	LKQ	2	Manufacturer	accessdata.fda.gov
Antibody To Htlv-1, Elisa	MTP	3	Manufacturer	accessdata.fda.gov
Antigen, Agglutinating, Echinococcus Spp.	GPF	1	Manufacturer	accessdata.fda.gov
Antigen, Cf (Including Cf Control), Cytomegalovirus	GQH	2	Manufacturer	accessdata.fda.gov
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	GQG	1	Manufacturer for export	accessdata.fda.gov
Antigen, Cf, (Including Cf Control), Varicella-Zoster	GQW	2	Manufacturer	accessdata.fda.gov
Antigen, Ebv, Capsid	MCD	1	Manufacturer	accessdata.fda.gov
Antigen, Elisa, Cryptococcus	MDU	2	Manufacturer	accessdata.fda.gov
Antigen, Fluorescent Antibody Test, Schistosoma Mansoni	GNH	1	Manufacturer	accessdata.fda.gov
Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus	GPD	1	Manufacturer	accessdata.fda.gov
Antigens, All, Leptospira Spp.	GRY	2	Manufacturer	accessdata.fda.gov
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.	GNC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antigens, If, Toxoplasma Gondii	GLZ	2	Manufacturer	accessdata.fda.gov
Antigens, Nontreponemal, All	GMQ	2	Manufacturer for export	accessdata.fda.gov
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	DBM	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	LJM	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	DHN	2	Manufacturer	accessdata.fda.gov
Antisera, All Groups, Streptococcus Spp.	GTZ	1	Manufacturer	accessdata.fda.gov
Antisera, All Leptospira Spp.	GRX	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Antisera, Cf, Herpesvirus Hominis 1,2	GQO	2	Manufacturer	accessdata.fda.gov
Antisera, Cf, Influenza Virus A, B, C	GNW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antisera, Control For Nontreponemal Tests	GMP	2	Manufacturer	accessdata.fda.gov
Antisera, Fluorescent, Herpesvirus Hominis 1,2	GQL	2	Manufacturer	accessdata.fda.gov
Antisera, Latex Agglutination, Cryptococcus Neoformans	GMD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antisera, Positive Control, Echinococcus Spp.	GPE	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Antiserum, Fluorescent, Epstein-Barr Virus	JRY	1	Manufacturer	accessdata.fda.gov
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control	DBE	2	Manufacturer	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Automated Urinalysis System	KQO	1	Manufacturer	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Manufacturer	accessdata.fda.gov
Beta-2-Glycoprotein I, Antigen, Antiserum, Control	DDN	1	Manufacturer	accessdata.fda.gov
Blood, Occult, Colorimetric, In Urine	JIO	2	Manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Manufacturer	accessdata.fda.gov
C. Trachomatis (Chlamydia Group)	MGM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calprotectin, Fecal	NXO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Chamber, Slide Culture	KIY	1	Manufacturer	accessdata.fda.gov
Chromatographic Separation, Cpk Isoenzymes	JHT	2	Manufacturer	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	MPQ	1	Manufacturer	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Repackager or relabeler	accessdata.fda.gov
Covid-19 Multi-Analyte Antigen Device	QMN	N	Manufacturer	accessdata.fda.gov
Cryptosporidium Spp.	MHJ	2	Manufacturer	accessdata.fda.gov
Dengue Serological Reagents	OSU	2	Manufacturer	accessdata.fda.gov
Dengue Virus Antigen Assay	QCU	2	Manufacturer	accessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	PMT	2	Repackager or relabeler	accessdata.fda.gov
Device, General Purpose, Microbiology, Diagnostic	LIB	1	Manufacturer for export	accessdata.fda.gov
Device, Microtiter Diluting/Dispensing	JTC	1	Manufacturer	accessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus Antigens	PSZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Manufacturer	accessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	1	Manufacturer	accessdata.fda.gov
Direct Agglutination Test, Toxoplasma Gondii	LLA	2	Manufacturer	accessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	1	Manufacturer	accessdata.fda.gov
Electrolyte Controls (Assayed And Unassayed)	JJR	1	Manufacturer	accessdata.fda.gov
Elisa, Antibody, West Nile Virus	NOP	2	Manufacturer	accessdata.fda.gov
Elisa, Trichinella Spiralis	MDT	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Enzyme Immunoassay, Fetal Fibronectin	LKV	3	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	LJC	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	LGC	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mumps Virus	LJY	1	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	LJZ	1	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rotavirus	LIQ	1	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubeola Igm	PCL	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	LFY	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	LIP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	MXJ	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	MYF	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, T. Cruzi	MIU	1	Manufacturer	accessdata.fda.gov
Epstein-Barr Virus, Other	LSE	1	Manufacturer	accessdata.fda.gov
Extractable Antinuclear Antibody, Antigen And Control	LLL	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Manufacturer	accessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	DAP	2	Manufacturer	accessdata.fda.gov
Forensic Evidence Sexual Assault Kit	OHE	2	Manufacturer	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Manufacturer	accessdata.fda.gov
Giardia Spp.	MHI	2	Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer for export	accessdata.fda.gov
Helicobacter Pylori	LYR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hemoglobin, Chain Specific, Antigen, Antiserum, Control	DAM	2	Manufacturer	accessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)	LOL	2	Manufacturer, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Hepatitis Delta Serological Reagents	LQI	3	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Manufacturer	accessdata.fda.gov
Immunoassay, Insulin-Like Growth Factor Binding Protein-1	OAM	1	Manufacturer	accessdata.fda.gov
Immunochemical, Thyroglobulin Autoantibody	JNL	2	Manufacturer	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Manufacturer	accessdata.fda.gov
Kit, Identification, Neisseria Gonorrhoeae	JSX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Kit, Screening, Staphylococcus Aureus	JWX	1	Manufacturer for export	accessdata.fda.gov
Kit, Screening, Trichomonas	JWZ	1	Repackager or relabeler	accessdata.fda.gov
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter	MVO	U	Manufacturer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test	QST	2	Manufacturer for export	accessdata.fda.gov
Latex Agglutination Assay, Rubella	LQN	2	Manufacturer for export	accessdata.fda.gov
Legionella, Spp., Elisa	MJH	2	Manufacturer	accessdata.fda.gov
Lipoprotein X, Antigen, Antiserum, Control	DEL	1	Manufacturer	accessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	2	Manufacturer	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Manufacturer	accessdata.fda.gov
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	DBL	2	Manufacturer	accessdata.fda.gov
NCI	NCI		Manufacturer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Manufacturer	accessdata.fda.gov
Norovirus Serological Reagent	OUC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device	PJD	2	Manufacturer	accessdata.fda.gov
Radioassay, Triiodothyronine Uptake	KHQ	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, 17-Hydroxyprogesterone	JLX	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Androstenedione	CIZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Manufacturer for export	accessdata.fda.gov
Radioimmunoassay, Digoxin (125-I)	LCS	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estriol	CGI	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estrone	CGF	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Human Growth Hormone	CFL	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Immunoreactive Insulin	CFP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroxine-Binding Globulin	CEE	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Manufacturer	accessdata.fda.gov
Reagent, Borrelia Serological Reagent	LSR	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Manufacturer	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Manufacturer	accessdata.fda.gov
Reagents For Detection Of Norovirus Nucleic Acid	PIQ	2	Manufacturer for export	accessdata.fda.gov
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	LHL	2	Manufacturer	accessdata.fda.gov
Reagents, Cysticercosis	MDJ	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Reagents, Test, Tetrahydrocannabinol	DKE	2	Manufacturer for export	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Manufacturer	accessdata.fda.gov
Station, Pipetting And Diluting, For Clinical Use	JQW	1	Manufacturer	accessdata.fda.gov
Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use	KSX	2	Manufacturer for export	accessdata.fda.gov
System, Identification, Hepatitis B Antigen	KSJ	3	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Manufacturer	accessdata.fda.gov
System, Test, C-Reactive Protein	DCN	2	Manufacturer	accessdata.fda.gov
System, Test, Carcinoembryonic Antigen	DHX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Infectious Mononucleosis	KTN	2	Manufacturer, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
System, Test, Systemic Lupus Erythematosus	DHC	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Manufacturer, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users	SEA	2	Manufacturer	accessdata.fda.gov
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	MOB	2	Manufacturer	accessdata.fda.gov
Test System, For Drugs Of Abuse	MGX	3	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test System, Nicotine, Cotinine, Metabolites	MRS	1	Repackager or relabeler	accessdata.fda.gov
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment	NSF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Manufacturer	accessdata.fda.gov
Test, Antigen, Nuclear, Epstein-Barr Virus	LLM	1	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	PVA	2	Manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Manufacturer	accessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	2	Manufacturer, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Manufacturer	accessdata.fda.gov
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis	NCD	3	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Manufacturer	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Manufacturer	accessdata.fda.gov
Test, Morphine, Over The Counter	NGI	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Manufacturer	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Manufacturer	accessdata.fda.gov
Test, Screening, For D Positive Fetal Rbc'S	LIM	2	Manufacturer for export	accessdata.fda.gov
Test, Sickle Cell	GHM	2	Manufacturer for export	accessdata.fda.gov
Test, Syphilis, Treponemal	MTN	N	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Manufacturer	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Manufacturer	accessdata.fda.gov
Test, Vaginal, Bacterial Sialidase	MXB	1	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Morphine	DNK	2	Manufacturer	accessdata.fda.gov
Thin Layer Chromatography, Tricyclic Antidepressant Drugs	MLK	2	Manufacturer	accessdata.fda.gov
Thyroglobulin, Antigen, Antiserum, Control	DDC	2	Manufacturer	accessdata.fda.gov
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	MTF	3	Repackager or relabeler	accessdata.fda.gov
Trichomonas Vaginalis Nucleic Acid Amplification Test System	OUY	2	Manufacturer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Manufacturer, Manufacturer for export	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 143.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 3, 2025	K250398	Innovita Flu A/B Antigen Rapid Test	PSZ	Substantially Equivalent	Innovita (Tangshan) Biological Technology Co., Ltd.	accessdata.fda.gov
July 31, 2023	K231698	AllTest Fentanyl Rapid Test (Urine)	DJG	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
January 31, 2022	K203272	Alltest Pregnancy Rapid Combo Test Cassette	JHI	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
August 27, 2018	K181473	DENV Detect NS1 ELISA	QCU	Substantially Equivalent	InBios International, Inc.	accessdata.fda.gov
July 20, 2018	K181017	Free Testosterone AccuBind ELISA Test System	CDZ	Substantially Equivalent	Monobind, Inc.	accessdata.fda.gov
February 23, 2018	K173303	INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)	DKZ	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
February 15, 2018	K173212	Instant-view-PLUS immunochemical Fecal Occult Blood Test	KHE	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
June 2, 2017	K162395	MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup	DIO	Substantially Equivalent	Mp Biomedicals, LLC	accessdata.fda.gov
December 16, 2016	K161947	Chagas Detect Plus Rapid Test	MIU	Substantially Equivalent	InBios International, Inc.	accessdata.fda.gov
June 24, 2016	K152122	Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)	DKZ	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
May 22, 2014	K140455	CAPTIA MEASLES IGM	PCL	Substantially Equivalent	Trinity Biotech USA	accessdata.fda.gov
October 18, 2013	K130213	QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE	LDJ	Substantially Equivalent	Lumiquick Diagnostics, Inc.	accessdata.fda.gov
October 7, 2013	K131645	INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)	DKZ	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
April 8, 2011	DEN100020	DENV DETECT IGM CAPTURE ELISA	OSU	Unknown	Inbios Intl., Inc.	accessdata.fda.gov
February 4, 2011	K101673	URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10	JIL	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
May 30, 2008	K072178	ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM	MXJ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 4, 2008	K063437	ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300	JLW	Substantially Equivalent	Monobind, Inc.	accessdata.fda.gov
July 5, 2007	K070317	ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM	LFY	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 21, 2007	K070660	INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST	KHE	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
May 7, 2007	K063545	MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE	DJG	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
July 21, 2006	K051958	MP RAPIDOXY TEST STRIP, MODEL 07RD-7073	DJG	Substantially Equivalent	Mp Biomedicals, LLC	accessdata.fda.gov
November 19, 2004	K042227	INSTANT-VIEW TROPONIN I TEST	MMI	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
November 19, 2004	K041817	WEST NILE DETECT IGM ELISA	NOP	Substantially Equivalent	Inbios Intl., Inc.	accessdata.fda.gov
November 26, 2003	K033079	CHLAMYDIA IGG ELISA TEST SYSTEM	LJC	Substantially Equivalent	Trinity Biotech USA	accessdata.fda.gov
November 26, 2003	K033051	LEGIONELLA PNEUMOPHILA IGG/IGM	MJH	Substantially Equivalent	Trinity Biotech USA	accessdata.fda.gov
August 22, 2003	K030860	ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300	KLI	Substantially Equivalent	Monobind	accessdata.fda.gov
July 10, 2003	K031059	IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96	MHJ	Substantially Equivalent	Ivd Research, Inc.	accessdata.fda.gov
June 10, 2003	K024360	INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST	LYR	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
March 6, 2003	K023297	URS-1B (BLOOD TEST)	JIO	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
March 5, 2003	K024113	IVD CRYPTO/GIARDIA DFA	MHI	Substantially Equivalent	Ivd Research, Inc.	accessdata.fda.gov
December 19, 2002	K022660	BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117	DRR	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
December 9, 2002	K022693	INSTANT-VIEW TCA URINE TEST	MLK	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
November 13, 2002	K022501	INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST	DJC	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
November 5, 2002	K022829	INSTANT-VIEW LH OVULATION PREDICTING TEST	CEP	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
September 17, 2002	K020583	IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96	MHI	Substantially Equivalent	Ivd Research, Inc.	accessdata.fda.gov
June 17, 2002	K021423	INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST	KHE	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
April 5, 2002	K020548	FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300	CEC	Substantially Equivalent	Monobind	accessdata.fda.gov
July 20, 2001	K003851	BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119	DCK	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
May 29, 2001	K010047	INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST	LCM	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
May 29, 2001	K003881	INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST	JXM	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
May 29, 2001	K003879	INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)	JXM	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
November 29, 2000	K001525	CAPTIA SYPHILIS-G ELISA TEST SYSTEM	LIP	Substantially Equivalent	Trinity Biotech, Plc	accessdata.fda.gov
October 2, 2000	K002294	BIOCHECK TESTOSTERONE EIA, MODEL BC-1115	CDZ	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
November 26, 1999	K992665	MACRA LP(A) ENZYME IMMUNOASSAY KIT	DFC	Substantially Equivalent	Trinity Biotech USA	accessdata.fda.gov
September 24, 1999	K992517	BIOCHECK FERRITIN ELISA MODEL BC-1025	DBF	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
August 12, 1999	K991820	HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI	LYR	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 25, 1999	K991610	ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.	DDC	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 22, 1999	K990993	BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003	JLW	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
June 17, 1999	K991179	ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM	DDC	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 2, 1999	K991432	BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007	KLI	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
June 2, 1999	K991311	TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005	CDP	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
March 26, 1999	K990207	GLIADIN IGA ELISA TEST SYSTEM	MST	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
March 26, 1999	K990204	GLIADIN IGG ELISA TEST SYSTEM	MST	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
March 18, 1999	K983656	HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM	LGC	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
February 16, 1999	K984080	INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST	JHI	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
February 16, 1999	K984079	INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST	JHI	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
February 16, 1999	K984077	INSTANT-VIEW PREGNANCY COMBO TEST	JHI	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
February 16, 1999	K984076	INSTANT-VIEW PREGNANCY URINE TEST	JHI	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
February 16, 1999	K984075	INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST	LCX	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
January 13, 1999	K982485	SERAQUEST CMV IGM	LFZ	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
October 16, 1998	K982281	SERAQUEST RUBELLA IGM	LFX	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
June 2, 1998	K981021	ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM	MID	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 2, 1998	K981014	ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM	MID	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
May 1, 1998	K980598	EBNA-1 IGM ELISA TEST SYSTEM	LLM	Substantially Equivalent	Clark Laboratories, Inc.	accessdata.fda.gov
February 4, 1998	K980088	T-UPTAKE MICROPLATE EIA	KHQ	Substantially Equivalent	Monobind	accessdata.fda.gov
November 5, 1997	K972295	SERAQUEST VZV IGG	LFY	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
October 29, 1997	K973196	ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS	MID	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
October 21, 1997	K971672	SERAQUEST TOXOPLASMA IGM	LGD	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
September 2, 1997	K972720	FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)	CGJ	Substantially Equivalent	Monobind	accessdata.fda.gov
August 20, 1997	K971503	MYCOPLASMA IGM ELISA TEST SYSTEM	LJZ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
August 8, 1997	K964424	ROTAVIRUS EIA	LIQ	Substantially Equivalent	Trinity Biotech, Inc.	accessdata.fda.gov
July 3, 1997	K971835	ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA	DDC	Substantially Equivalent	Monobind	accessdata.fda.gov
July 3, 1997	K971834	ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA	JNL	Substantially Equivalent	Monobind	accessdata.fda.gov
June 24, 1997	K971921	PROLACTIN (PRL) HORMONE MICROPLATE ELISA	CFT	Substantially Equivalent	Monobind	accessdata.fda.gov
June 24, 1997	K971780	THYROTROPIN(TSH) ELISA	JLW	Substantially Equivalent	Monobind	accessdata.fda.gov
June 16, 1997	K971779	TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA	CDP	Substantially Equivalent	Monobind	accessdata.fda.gov
June 16, 1997	K971709	TOTAL THROXINE MICROPLATE EIA(225-300)	KLI	Substantially Equivalent	Monobind	accessdata.fda.gov
June 16, 1997	K970150	MYCOPLASMA IGG ELISA TEST SYSTEM	LJZ	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 10, 1997	K964449	ANCA SCREEN ELISA TEST SYSTEM	MOB	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 10, 1997	K964448	PROTEINASE-3 IGG ELISA TEST SYSTEM	MOB	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 10, 1997	K964446	MYELOPEROXIDASE ELISA TEST SYSTEM	MOB	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 8, 1997	K970250	CLINISTRIP	JIL	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
November 25, 1996	K962019	C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST	DCK	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
November 25, 1996	K962015	RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST	DHR	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
September 4, 1996	K961053	SERAQUEST RUBELLA IGG	LFX	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
July 24, 1996	K961012	VZV IGG ELISA TEST SYSTEM	LFY	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
July 18, 1996	K961204	MUMPS IGG TEST	LJY	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 17, 1996	K960092	SERAQUEST TOXOPLASMA IGG	LGD	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
March 11, 1996	K954977	URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)	JRE	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
February 23, 1996	K954191	SERAQUEST CMV IGG	LFZ	Substantially Equivalent	Quest Intl., Inc.	accessdata.fda.gov
September 25, 1995	K944449	EBV-VCA IGM ELISA TEST STSTEM	LSE	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
May 19, 1995	K930272	HEMAGEN CHAGAS' KIT (EIA METHOD)	MIU	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
May 5, 1995	K932742	EBNA IGG ELISA TEST SYSTEM	LLM	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
April 24, 1995	K943436	URINE REAGENT STRIPS-8 PARAMETERS	JJB	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
March 24, 1995	K942648	IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET	JIL	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
February 22, 1995	K946122	HEMAGEN ENA SCL-70 KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
February 22, 1995	K946121	HEMAGEN ENA SS-A KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
September 9, 1994	K940469	URINE REAGENT STRIP-3 PARAMETERS	JIL	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
June 10, 1994	K941409	ENA PROFILE-6 ELISA TEST SYSTEM	LJM	Substantially Equivalent	Zeus Scientific, Inc.	accessdata.fda.gov
June 3, 1994	K941394	STAT FAX 2600	JQW	Substantially Equivalent	Awareness Technology, Inc.	accessdata.fda.gov

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Updated July 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.