Data / Medical devices / United States / Jant Pharmacal Corp.

Jant Pharmacal Corp.: FDA-registered device maker in Encino, CA, United States, 58 510(k) clearances

Name: Jant Pharmacal Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jant Pharmacal Corp. is registered with the FDA (registration 2030633) in Encino, CA, United States. It lists 64 device types. The FDA files 58 510(k) clearances under its listings, the newest dated March 17, 2023. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch Jant Pharmacal Corp.

FDA registration number: 2030633
FEI number: 3000210620
Address: 16530 Ventura Blvd Ste 512, Encino, CA, United States, 91436
Owner or operator: JANT PHARMACAL CORP. (9024922)
Roles: Complaint file establishment
First device listed: March 5, 1996
Registered through: 2026
Brand names listed: ACCUTEST AMPHETAMINE DRUG SCREEN, ACCUTEST BARBITURATE DRUG SCREEN, ACCUTEST BENZODIAZEPINE DRUG SCREEN, ACCUTEST COCAINE DRUG SCREEN, ACCUTEST FINGER PUL, ACCUTEST METHADONE DRUG SCREEN, ACCUTEST METHAMPHE, ACCUTEST MIDSTREAM PREGNANCY TEST and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	JMA	1	Complaint file establishment	accessdata.fda.gov
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	DIC	2	Complaint file establishment	accessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.	GTY	1	Complaint file establishment	accessdata.fda.gov
Automated Urinalysis System	KQO	1	Complaint file establishment	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Complaint file establishment	accessdata.fda.gov
Blood, Occult, Colorimetric, In Urine	JIO	2	Complaint file establishment	accessdata.fda.gov
Blood, Occult, Enzymatic Method, In Urine	JIP	2	Complaint file establishment	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Complaint file establishment	accessdata.fda.gov
Colorimetric Method, Triglycerides	JGY	1	Complaint file establishment	accessdata.fda.gov
Devices, Breath Trapping, Alcohol	DJZ	1	Complaint file establishment	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Complaint file establishment	accessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	1	Complaint file establishment	accessdata.fda.gov
Drug Mixture Control Materials	DIF	1	Complaint file establishment	accessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	1	Complaint file establishment	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Complaint file establishment	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Nicotine And Nicotine Metabolites	MKU	1	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Complaint file establishment	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Complaint file establishment	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Complaint file establishment	accessdata.fda.gov
Helicobacter Pylori	LYR	1	Complaint file establishment	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Complaint file establishment	accessdata.fda.gov
Kit, Screening, Urine	JXA	1	Complaint file establishment	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Complaint file establishment	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Complaint file establishment	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Complaint file establishment	accessdata.fda.gov
NCI	NCI		Complaint file establishment	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Complaint file establishment	accessdata.fda.gov
Oximeter	DQA	2	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Complaint file establishment	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Complaint file establishment	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Complaint file establishment	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment	accessdata.fda.gov
Solution, Copper Sulfate For Specific Gravity Determinations	KSL	1	Complaint file establishment	accessdata.fda.gov
System Accessories, Extracorporeal	KXM	2	Complaint file establishment	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Complaint file establishment	accessdata.fda.gov
System, Test, Infectious Mononucleosis	KTN	2	Complaint file establishment	accessdata.fda.gov
Test System, Nicotine, Cotinine, Metabolites	MRS	1	Complaint file establishment	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Complaint file establishment	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Complaint file establishment	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Complaint file establishment	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Complaint file establishment	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Complaint file establishment	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Complaint file establishment	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Complaint file establishment	accessdata.fda.gov
Test, Morphine, Over The Counter	NGI	2	Complaint file establishment	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Complaint file establishment	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Complaint file establishment	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Complaint file establishment	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Complaint file establishment	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Complaint file establishment	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Complaint file establishment	accessdata.fda.gov
Thin Layer Chromatography, Morphine	DNK	2	Complaint file establishment	accessdata.fda.gov
U.V. Spectrometry, Tricyclic Antidepressant Drugs	LFH	2	Complaint file establishment	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Complaint file establishment	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 17, 2023	K223162	Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT	LDJ	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
December 3, 2018	K182701	Wondfo T-Cup Multi-Drug Urine Test Cup	NFT	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	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
August 2, 2017	K163704	Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card	JXM	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
May 23, 2016	K153597	Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card	JXM	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
February 25, 2014	K133968	WONDFO MULTI-DRUG URINE TEST CUP, PANEL	DKZ	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
January 31, 2014	K133343	WONDFO RAPID STREP A TEST	GTY	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	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
June 21, 2013	K130295	LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.	NBW	Substantially Equivalent	Infopia Co, Ltd.	accessdata.fda.gov
April 10, 2013	K123703	HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)	LCX	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
April 17, 2012	K111999	HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL	JIO	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
September 14, 2011	K110309	FOB ONE STEP RAPID TEST	KHE	Substantially Equivalent	Orient Gene Biotech	accessdata.fda.gov
August 6, 2010	K093879	MISSION SALIVA ALCOHOL TEST STRIP	DIC	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
April 27, 2010	K091472	URITEST 50 AND URITEST 500 URINE ANALYZER	KQO	Substantially Equivalent	Arj Medical, Inc.	accessdata.fda.gov
January 28, 2010	K093143	MISSION BREATH ALCOHOL DETECTOR	DJZ	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
December 1, 2009	K090405	LIPIDPRO SYSTEM	NBW	Substantially Equivalent	Infopia Co, Ltd.	accessdata.fda.gov
December 19, 2008	K082898	AMEDICA DRUG SCREEN TEST CUP	NGL	Substantially Equivalent	Amedica Biotech, Inc.	accessdata.fda.gov
March 28, 2008	K071489	HOMECHECK MULTIPLE DRUG CUP TEST	DKZ	Substantially Equivalent	Tianjin New Bay Bioresearch Co., Ltd.	accessdata.fda.gov
January 14, 2008	K073431	FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T	KHE	Substantially Equivalent	Tianjin New Bay Bioresearch Co., Ltd.	accessdata.fda.gov
May 11, 2007	K063693	FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST	KHE	Substantially Equivalent	New Bay Bioresearch Co. , Ltd.	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
January 26, 2007	K061419	TECO MICROALBUMIN 2-1 COMBO STRIPS	JIR	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
December 5, 2006	K052719	URITEST 10 URINALYSIS REAGENT STRIPS	CDM	Substantially Equivalent	Arj Medical, Inc.	accessdata.fda.gov
September 6, 2006	K061742	URYXXON RELAX URINE ANALYZER	JIL	Substantially Equivalent	Macherey-Nagel GmbH & Co. KG	accessdata.fda.gov
May 1, 2006	K052708	PYLO-PLUS	LYR	Substantially Equivalent	Arj Medical, Inc.	accessdata.fda.gov
April 21, 2006	K060466	ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE	DJG	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
June 8, 2005	K050878	ON CALL MULTI-DRUG HOME TEST CUP	LDJ	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
March 11, 2005	K050050	ON CALL MULTI-DRUG HOME TEST	LDJ	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
September 14, 2004	K041964	MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS	DQA	Substantially Equivalent	Mediaid, Inc.	accessdata.fda.gov
September 10, 2004	K040178	PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE	DQA	Substantially Equivalent	S.P.O. Medical Equipment, Ltd.	accessdata.fda.gov
August 30, 2004	K041685	ACON MULTI-CLIN DRUG SCREEN TEST DEVICE	DKZ	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
May 19, 2004	K040445	ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE	JXN	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
February 17, 2004	K033047	ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE	DJG	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
August 4, 2003	K031759	ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD	DKZ	Substantially Equivalent	ACON Laboratories, 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
October 28, 2002	K022589	ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE	LAF	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
October 18, 2002	K021688	NICALERT	MRS	Substantially Equivalent	Nymox Pharmaceutical Corporation	accessdata.fda.gov
July 17, 2002	K021526	ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE	LFG	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
December 18, 2001	K013380	ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE	DJG	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
November 9, 2001	K012824	ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE	DIS	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
October 15, 2001	K012595	ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE	DJR	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
September 17, 2001	K012300	ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE	JXM	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
August 9, 2001	K011730	ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE	LCM	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
July 31, 2001	K011673	ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE	DKZ	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
July 31, 2001	K011672	ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE	LAF	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
July 30, 2001	K011353	ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE	DJG	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
July 9, 2001	K010841	ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE	DIO	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
May 7, 2001	K010582	ACON STREP A RAPID TEST STRIP	GTY	Substantially Equivalent	Acon Laboratories Co.	accessdata.fda.gov
March 15, 2001	K003557	ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)	LDJ	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
September 17, 1999	K991927	MEDI-TEST COMBI 11	JIL	Substantially Equivalent	Macherey-Nagel-Duren	accessdata.fda.gov
June 2, 1999	K990658	THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY	JLW	Substantially Equivalent	Little Nell Labs, 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
November 25, 1998	K983386	BIOSTREP A-DIRECT STREP A ANTIGEN TEST	GTY	Substantially Equivalent	Princeton BioMeditech Corp.	accessdata.fda.gov
February 4, 1997	K961024	BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB	KTN	Substantially Equivalent	Princeton BioMeditech Corp.	accessdata.fda.gov
April 6, 1993	K930488	BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST	LCX	Substantially Equivalent	Syntron Bioresearch, Inc.	accessdata.fda.gov
September 30, 1988	K882211	URISCREEN	JXA	Substantially Equivalent	Diatech Diagnostica , Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 17, 2023. 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.