Data / Medical devices / United States / Teco Diagnostics

Teco Diagnostics: FDA-registered device maker in Anaheim, CA, United States, 157 510(k) clearances

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

Teco Diagnostics is registered with the FDA (registration 1832216) in Anaheim, CA, United States. It lists 122 device types. The FDA files 157 510(k) clearances under its listings, the newest dated July 6, 2022. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1832216
Address: 1268 North Lakeview Ave., Anaheim, CA, United States, 92807
Owner or operator: TECO DIAGNOSTICS (1832216)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: September 27, 1983
Registered through: 2026
Brand names listed: ACID PHOSPHATASE REAGENT SET, ACTIVATED PARTIAL THROMBOPLASTIN, ALKALINE PHOSPHATASE, ALT (SGPT) Kinetic, ALT(SGPT), Color, End Point, ALT/SGPT, AMP Amphetamine Card, AMYLASE (COLORIMETRIC) REAGENT SET and more

Devices it lists

Device	Product code	Class	Role	Source
Acid Phosphatase, Naphthyl Phosphate	CKB	2	Manufacturer	accessdata.fda.gov
Acid Phosphatase, Thymolphthale Inmonophosphate	CKE	2	Manufacturer	accessdata.fda.gov
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase	JMK	1	Manufacturer	accessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)	KNK	1	Manufacturer	accessdata.fda.gov
Activated Partial Thromboplastin	GFO	2	Repackager or relabeler	accessdata.fda.gov
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	DIC	2	Manufacturer	accessdata.fda.gov
Alkaline Picrate, Colorimetry, Creatinine	CGX	2	Manufacturer	accessdata.fda.gov
Amplifier And Signal Conditioner, Biopotential	DRR	2	Repackager or relabeler	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antigens, Nontreponemal, All	GMQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	LJM	2	Repackager or relabeler	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	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
Berthelot Indophenol, Urea Nitrogen	CDL	2	Manufacturer	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Manufacturer	accessdata.fda.gov
Blood, Occult, Colorimetric, In Urine	JIO	2	Manufacturer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catalytic Methods, Amylase	JFJ	2	Manufacturer	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Manufacturer	accessdata.fda.gov
Colorimetric Method, Cpk Or Isoenzymes	JHY	2	Manufacturer	accessdata.fda.gov
Colorimetry, Cholinesterase	DIH	1	Manufacturer	accessdata.fda.gov
Cresolphthalein Complexone, Calcium	CIC	2	Manufacturer	accessdata.fda.gov
Cyanomethemoglobin Reagent And Standard Solution	GJZ	2	Manufacturer	accessdata.fda.gov
Devices, Breath Trapping, Alcohol	DJZ	1	Repackager or relabeler	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Manufacturer	accessdata.fda.gov
Diazo, Ast/Sgot	CIQ	2	Manufacturer	accessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	1	Manufacturer	accessdata.fda.gov
Diethyldithiocarbamate (Colorimetric), Copper	JKZ	1	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
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Manufacturer	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Manufacturer	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Repackager or relabeler	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Repackager or relabeler	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Manufacturer	accessdata.fda.gov
Fluorometry, Morphine	DJJ	2	Repackager or relabeler	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Repackager or relabeler	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Helicobacter Pylori	LYR	1	Manufacturer	accessdata.fda.gov
Hexokinase, Glucose	CFR	2	Manufacturer	accessdata.fda.gov
Hydrazone Colorimetry, Alt/Sgpt	CKD	1	Manufacturer	accessdata.fda.gov
Ige, Antigen, Antiserum, Control	DGC	2	Repackager or relabeler	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Repackager or relabeler	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Manufacturer	accessdata.fda.gov
Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen	JNF	1	Manufacturer	accessdata.fda.gov
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	1	Manufacturer	accessdata.fda.gov
Kit, Screening, Urine	JXA	1	Manufacturer	accessdata.fda.gov
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter	MVO	U	Repackager or relabeler	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Repackager or relabeler	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Manufacturer	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Manufacturer	accessdata.fda.gov
Mercuric Thiocyanate, Colorimetry, Chloride	CHJ	2	Manufacturer	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Repackager or relabeler	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	2	Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Manufacturer	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Repackager or relabeler	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Manufacturer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Manufacturer	accessdata.fda.gov
Olive Oil Emulsion (Turbidimetric), Lipase	CET	1	Manufacturer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Manufacturer	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Manufacturer	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Manufacturer	accessdata.fda.gov
Plasma, Coagulation Control	GGN	2	Repackager or relabeler	accessdata.fda.gov
Qualitative Chemical Reactions, Urinary Calculi (Stone)	JNQ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Manufacturer for export	accessdata.fda.gov
Radioimmunoassay, Human Growth Hormone	CFL	1	Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer for export	accessdata.fda.gov
Radioimmunoassay, Phencyclidine	LCL	U	Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Manufacturer for export	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Manufacturer for export	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Reagents, Test, Tetrahydrocannabinol	DKE	2	Repackager or relabeler	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2	Repackager or relabeler	accessdata.fda.gov
Stains, Microbiologic	JTS	1	Manufacturer	accessdata.fda.gov
Station, Pipetting And Diluting, For Clinical Use	JQW	1	Repackager or relabeler	accessdata.fda.gov
Sulfophosphovanillin, Colorimetry, Total Lipids	CFD	1	Manufacturer	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, C-Reactive Protein	DCN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Infectious Mononucleosis	KTN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Manufacturer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Manufacturer	accessdata.fda.gov
System, Test, Systemic Lupus Erythematosus	DHC	2	Repackager or relabeler	accessdata.fda.gov
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	MSV	2	Repackager or relabeler	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Manufacturer	accessdata.fda.gov
Tetraphenyl Borate, Colorimetry, Potassium	CEJ	2	Manufacturer	accessdata.fda.gov
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase	CFH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Repackager or relabeler	accessdata.fda.gov
Thin Layer Chromatography, Morphine	DNK	2	Manufacturer	accessdata.fda.gov
Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes	CIO	2	Manufacturer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Manufacturer	accessdata.fda.gov
Uranyl Acetate/Zinc Acetate, Sodium	CEI	2	Manufacturer	accessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	2	Manufacturer	accessdata.fda.gov
Urinalysis Controls (Assayed And Unassayed)	JJW	1	Repackager or relabeler	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Manufacturer, Repackager or relabeler, Specification developer	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 157.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 6, 2022	K220475	Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)	QRL	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.	accessdata.fda.gov
September 21, 2017	K170118	Scanostics UTI Check Application Test System	JMT	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
April 21, 2017	K160179	VivaChek Ino Blood Glucose Monitoring System	NBW	Substantially Equivalent	Vivachek Laboratories, Inc.	accessdata.fda.gov
July 22, 2016	K160372	URITEK TC-201 URINE CHEMISTRY TEST SYSTEM	JIL	Substantially Equivalent	Teco Diagnostics, Inc.	accessdata.fda.gov
March 7, 2016	K152835	URITEK TC-201 URINE CHEMISTRY TEST SYSTEM	JFY	Substantially Equivalent	Teco Diagnostics, Inc.	accessdata.fda.gov
October 2, 2015	K150063	One Step hCG Pregnancy Test	LCX	Substantially Equivalent	Coretests, Inc.	accessdata.fda.gov
July 24, 2015	K141289	TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS	JIL	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
May 29, 2014	K131600	URS-2GP (GLUCOSE PROTEIN) URINE STRIPS	JIL	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
May 14, 2014	K131069	QUICKSCREEN AMPHETINE 500 TEST	DKZ	Substantially Equivalent	Phamatech, Inc.	accessdata.fda.gov
April 24, 2012	K103230	AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION	CGA	Substantially Equivalent	Bestgen Biotech Corp.	accessdata.fda.gov
March 13, 2012	K103116	AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM	CGA	Substantially Equivalent	Bestgen Biotech Corp.	accessdata.fda.gov
February 28, 2012	K111456	MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM	NBW	Substantially Equivalent	Tianjin Empecs Medical Device Co., Ltd.	accessdata.fda.gov
February 1, 2012	K103295	QUICKSCREEN COCAINE 150 SCREENING TEST	DIO	Substantially Equivalent	Phamatech, Inc.	accessdata.fda.gov
October 4, 2011	K111206	TECO DIAGNOSTICS SALIVA ALCOHOL TEST	DIC	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
February 17, 2011	K100024	TECO DIAGNOSTICS UTI DETECTION STRIPS	JMT	Substantially Equivalent	Teco Diagnostics	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
January 28, 2011	K102664	HEMA SCREEN ER	KHE	Substantially Equivalent	Immunostics Inc.,	accessdata.fda.gov
November 18, 2009	K091714	ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579	DJZ	Substantially Equivalent	Skyfine Inc. Limited	accessdata.fda.gov
May 8, 2008	K073370	TC MATRIX CLINICAL CHEMISTRY ANALYZER	JJE	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
April 18, 2008	K072548	CREATINE KINASE LIQUID REAGENT, MODEL C519-440	CGS	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
January 26, 2007	K061419	TECO MICROALBUMIN 2-1 COMBO STRIPS	JIR	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
July 28, 2006	K060354	ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000	JXM	Substantially Equivalent	Acro Biotech, LLC	accessdata.fda.gov
July 14, 2006	K061065	FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25	KHE	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
June 15, 2006	K060364	VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE	JKA	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
June 15, 2006	K053037	ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100	DJG	Substantially Equivalent	Acro Biotech, LLC	accessdata.fda.gov
June 6, 2006	K053034	ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000	LDJ	Substantially Equivalent	Acro Biotech, LLC	accessdata.fda.gov
May 5, 2006	K053035	ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000	DIO	Substantially Equivalent	Acro Biotech, LLC	accessdata.fda.gov
May 3, 2006	K060353	ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000	LCM	Substantially Equivalent	Acro Biotech, LLC	accessdata.fda.gov
February 9, 2006	K053032	ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000	DKZ	Substantially Equivalent	Acro Biotech, LLC	accessdata.fda.gov
August 16, 2005	K051526	URITEK-720+ URINE ANALYZER	KQO	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
August 8, 2005	K051200	HEMOGLOBIN A1C REAGENT SET	LCP	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
August 8, 2005	K051121	DIRECT LDL CHOLESTEROL, MODEL L530-60H	MRR	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
July 26, 2005	K050823	DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR	LBR	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
June 28, 2005	K050178	HBA1C ENZYMATIC ASSAY	LCP	Substantially Equivalent	General Atomics	accessdata.fda.gov
December 29, 2004	K043167	PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X	JXM	Substantially Equivalent	Phamatech, Inc.	accessdata.fda.gov
December 29, 2004	K042975	AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II	DIS	Substantially Equivalent	Ameditech, Inc.	accessdata.fda.gov
November 19, 2004	K042227	INSTANT-VIEW TROPONIN I TEST	MMI	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
June 16, 2004	K040030	BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114	DCN	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
May 10, 2004	K040920	AMYLASE LIQUID REAGENT, MODEL A532-200	JFJ	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
March 8, 2004	K040092	AMEDITECH IMMU TEST DRUG SCREEN PANEL	DKZ	Substantially Equivalent	Ameditech, Inc.	accessdata.fda.gov
October 14, 2003	K032868	REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139	MID	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
August 4, 2003	K023279	GLUCOLEADER VALUE	NBW	Substantially Equivalent	Hmd Biomedical, 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
December 19, 2002	K022660	BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117	DRR	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
November 1, 2002	K022021	VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT	GFO	Substantially Equivalent	Vital Scientific N.V.	accessdata.fda.gov
July 23, 2002	K022046	VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL	GGN	Substantially Equivalent	Vital Scientific N.V.	accessdata.fda.gov
June 17, 2002	K021423	INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST	KHE	Substantially Equivalent	Alfa Scientific Designs, Inc.	accessdata.fda.gov
March 21, 2002	K020175	URS-IG (GLUCOSE TEST)	JIL	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
January 8, 2002	K013062	BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT	MMI	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
December 6, 2001	K013412	AT HOME DRUG TEST, MODEL 9069	MVO	Substantially Equivalent	Phamatech, Inc.	accessdata.fda.gov
November 30, 2001	K012484	AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE	DKZ	Substantially Equivalent	Ameditech, Inc.	accessdata.fda.gov
October 22, 2001	K011814	AMEDITECH IMMUTEST DRUG SCREEN COC	DIO	Substantially Equivalent	Ameditech, Inc.	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
June 25, 2001	K010239	COCAINE DIPSTICK TEST, MODEL D747-A	DIO	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
April 26, 2001	K003987	URS-1K (KETONE TESST)	JIN	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
October 2, 2000	K002294	BIOCHECK TESTOSTERONE EIA, MODEL BC-1115	CDZ	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
September 26, 2000	K001022	BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061	JZG	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
February 8, 2000	K000102	GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150	CFR	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
February 4, 2000	K000131	QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04	LDJ	Substantially Equivalent	Phamatech	accessdata.fda.gov
January 20, 2000	K000067	ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H	CJE	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
December 16, 1999	K994093	AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C	LCL	Substantially Equivalent	Phamatech	accessdata.fda.gov
September 24, 1999	K992517	BIOCHECK FERRITIN ELISA MODEL BC-1025	DBF	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
September 21, 1999	K992528	BIOCHECK IGE ELISA, MODEL BC-1035	DGC	Substantially Equivalent	Biocheck, Inc.	accessdata.fda.gov
July 22, 1999	K991741	BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027	JHI	Substantially Equivalent	Biocheck, 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 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
February 5, 1999	K982938	QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153	DJR	Substantially Equivalent	Phamatech	accessdata.fda.gov
January 28, 1999	K982634	DRYSPOT INFECTIOUS MONONUCLEOSIS KIT	KTN	Substantially Equivalent	Oxoid , Ltd.	accessdata.fda.gov
June 29, 1998	K981650	AST/SGOT LIQUID REAGENT - KINETIC METHOD	CIT	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
June 3, 1998	K981687	QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1	JXM	Substantially Equivalent	Phamatech	accessdata.fda.gov
April 16, 1998	K981106	UREA NITROGEN (BUN) LIQUID REAGENT	CDQ	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
April 9, 1998	K974059	ONE STEP MIDSTREAM HCG PREGNANCY TEST	LCX	Substantially Equivalent	International Newtech Development, Inc.	accessdata.fda.gov
April 1, 1998	K980865	QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131	DKZ	Substantially Equivalent	Phamatech	accessdata.fda.gov
August 20, 1997	K972619	QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)	DJG	Substantially Equivalent	Phamatech	accessdata.fda.gov
July 3, 1997	K970579	ONE STEP MORPHINE CARD TEST	DNK	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
July 3, 1997	K970548	ONE STEP MARIJUANA CARD TEST	LDJ	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
April 8, 1997	K970250	CLINISTRIP	JIL	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
February 11, 1997	K964536	ONE-STEP DIPSTICK PREGNANCY TEST	JHI	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
February 11, 1997	K964462	ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST	JHI	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
February 11, 1997	K964461	ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST	JHI	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
October 24, 1996	K961864	CSF/URINE TOTAL PROTEIN	CEK	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
September 11, 1996	K961629	THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST	JLW	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
March 11, 1996	K954977	URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)	JRE	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
January 29, 1996	K955438	URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)	JIR	Substantially Equivalent	Teco Diagnostics	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
March 20, 1995	K942735	CARBON DIOXIDE (C02)	KHS	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
March 13, 1995	K941427	SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)	JMK	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
October 4, 1994	K936245	MULTI ANALYTE LINEARITY SET	JJY	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
September 9, 1994	K940469	URINE REAGENT STRIP-3 PARAMETERS	JIL	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
April 15, 1994	K936031	ONE STEP PREGNANCY TEST	JHI	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
November 5, 1993	K931183	GLYCOHEMOGLOBIN	LCP	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
November 5, 1993	K931080	AMYLASE REAGENT SET (KINETIC)	JFJ	Substantially Equivalent	Teco Diagnostics	accessdata.fda.gov
August 9, 1993	K932551	ACCUTEX IM LATEX TEST	KTN	Substantially Equivalent	J.S. Medical Assoc.	accessdata.fda.gov
November 2, 1992	K924248	ACCUTEX SLE LATEX TEST	LJM	Substantially Equivalent	J.S. Medical Assoc.	accessdata.fda.gov
October 1, 1992	K923376	VISUAL HCG PREGNANCY TEST	JHI	Substantially Equivalent	Tech-Co, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 14, 2011	60476	Not yet classified	Terminated	Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a g	This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets (Refer to next paragraph). Sampling s	accessdata.fda.gov
October 1, 2010	57157	Not yet classified	Terminated	Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and d	This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Wit	accessdata.fda.gov
December 22, 2005	34304	Not yet classified	Terminated	Uritek TC-101Urine Analyzer, catalog number TC-101	When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative.	accessdata.fda.gov

Compare with other makers

Updated July 6, 2022. 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.