Tech-Co, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
36
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTJune 28, 1996
K923376VISUAL HCG PREGNANCY TESTOctober 1, 1992
K920766T4 EIA BEAD ASSAYApril 17, 1992
K920716DIRECT PREGNANCY TESTMarch 24, 1992
K902574POTASSIUM REAGENT SETJuly 10, 1990
K901561IRON/TOTAL IRON BINDING CAPACITYMay 17, 1990
K883387ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)October 13, 1988
K883386CHLORIDEOctober 6, 1988
K883683HEMOGLOBINOctober 6, 1988
K881172BILIRUBIN (DIRECT)June 7, 1988
K881173ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)June 7, 1988
K881626GAMMA-GLUTAMYL TRANSFERASEMay 27, 1988
K881171PHOSPHORUS (INORGANIC)April 28, 1988
K880177ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHATApril 5, 1988
K880629CREATININEMarch 23, 1988
K880630LACTATE DEHYDROGENASE (LDH-L)March 16, 1988
K880628TRIGLYCERIDES (GPO-TRINDER)March 15, 1988
K874846GLUCOSE (HEXOKINASE)March 3, 1988
K880178CREATINE KINASE (COLORIMETRIC METHOD)February 18, 1988
K880176HDL CHOLESTEROL PRECIPITATING REAGENTFebruary 18, 1988