Medical Device Manufacturer · US , Troy , MI

Tech-Co, Inc.

36 submissions · 36 cleared · Since 1986
36
Total
36
Cleared
0
Denied

Tech-Co, Inc. — FDA 510(k) Submissions

Tech-Co, Inc. has submitted 36 FDA 510(k) premarket notifications since 1986, of which 36 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Agglutination Method, Human Chorionic Gonadotropin, Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides, Diazo Colorimetry, Bilirubin, Bromcresol Green Dye-binding, Albumin, Hydrazone Colorimetry, Alt/sgpt . Use the specialty filter in the sidebar to narrow results.

36 devices
1–25 of 36
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
K921968 · JHJ Agglutination Method,... · Chemistry
Jun 1996 1523d
VISUAL HCG PREGNANCY TEST
K923376 · JHI Visual, Pregnancy Hcg,... · Chemistry
Oct 1992 84d
T4 EIA BEAD ASSAY
K920766 · CDX Radioimmunoassay, Total... · Chemistry
Apr 1992 58d
DIRECT PREGNANCY TEST
K920716 · JHJ Agglutination Method,... · Chemistry
Mar 1992 35d
POTASSIUM REAGENT SET
K902574 · CEJ Tetraphenyl Borate,... · Chemistry
Jul 1990 29d
IRON/TOTAL IRON BINDING CAPACITY
K901561 · JIY Photometric Method, Iron... · Chemistry
May 1990 44d
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)
K883387 · CKD Hydrazone Colorimetry,... · Chemistry
Oct 1988 64d
CHLORIDE
K883386 · CHJ Mercuric Thiocyanate,... · Chemistry
Oct 1988 57d
HEMOGLOBIN
K883683 · GJZ Cyanomethemoglobin... · Hematology
Oct 1988 38d
BILIRUBIN (DIRECT)
K881172 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jun 1988 81d
ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)
K881173 · CIQ Diazo, Ast/sgot · Chemistry
Jun 1988 81d
GAMMA-GLUTAMYL TRANSFERASE
K881626 · JQB Kinetic Method,... · Chemistry
May 1988 45d
PHOSPHORUS (INORGANIC)
K881171 · CEO Phosphomolybdate... · Chemistry
Apr 1988 38d
ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT
K880177 · CIO Thymolphthalein... · Chemistry
Apr 1988 81d
CREATININE
K880629 · CGX Alkaline Picrate,... · Chemistry
Mar 1988 36d
LACTATE DEHYDROGENASE (LDH-L)
K880630 · CFH Tetrazolium Int... · Chemistry
Mar 1988 29d
TRIGLYCERIDES (GPO-TRINDER)
K880628 · CDT Lipase... · Chemistry
Mar 1988 28d
GLUCOSE (HEXOKINASE)
K874846 · CFR Hexokinase, Glucose · Chemistry
Mar 1988 100d
ASPARTATE AMINOTRANSFERASE AST/SGOT
K875071 · CIT Nadh Oxidation/nad... · Chemistry
Feb 1988 71d
HDL CHOLESTEROL PRECIPITATING REAGENT
K880176 · LBR Ldl & Vldl Precipitation,... · Chemistry
Feb 1988 34d
CREATINE KINASE (COLORIMETRIC METHOD)
K880178 · JHY Colorimetric Method, Cpk... · Chemistry
Feb 1988 34d
BILIRUBIN (TOTAL)
K875069 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jan 1988 33d
ALBUMIN, BROMCRESOL GREEN DYE-BINDING
K875070 · CIX Bromcresol Green... · Chemistry
Jan 1988 33d
MAGNESIUM
K874847 · JGJ Photometric Method,... · Chemistry
Dec 1987 24d
LACTATE DEHYDROGENASE LDH-L
K874848 · CFJ Nad Reduction/nadh... · Chemistry
Dec 1987 24d
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