Medical Device Manufacturer · US , Troy , MI

Tech-Co, Inc. - FDA 510(k) Cleared Devices

36 submissions · 36 cleared · Since 1986

36

Total

36

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tech-Co, Inc. Chemistry ✕

35 devices

1-12 of 35

Cleared Jun 28, 1996

IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST

Chemistry · 1523d

Cleared Oct 01, 1992

VISUAL HCG PREGNANCY TEST

Chemistry · 84d

Cleared Apr 17, 1992

T4 EIA BEAD ASSAY

Chemistry · 58d

Cleared Mar 24, 1992

DIRECT PREGNANCY TEST

Chemistry · 35d

Cleared Jul 10, 1990

POTASSIUM REAGENT SET

Chemistry · 29d

Cleared May 17, 1990

IRON/TOTAL IRON BINDING CAPACITY

Chemistry · 44d

Cleared Oct 13, 1988

ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)

Chemistry · 64d

Cleared Oct 06, 1988

Chemistry · 57d

Cleared Jun 07, 1988

BILIRUBIN (DIRECT)

Chemistry · 81d

Cleared Jun 07, 1988

ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)

Chemistry · 81d

Cleared May 27, 1988

GAMMA-GLUTAMYL TRANSFERASE

Chemistry · 45d

Cleared Apr 28, 1988

PHOSPHORUS (INORGANIC)

Chemistry · 38d