Biochemical Trade, Inc. - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biochemical Trade, Inc. Chemistry ✕
18 devices
Cleared
Nov 21, 1994
CREATINE KINASE MB DETERMINATION (UV)
Chemistry
151d
Cleared
May 15, 1991
TOTAL BILIRUBIN REAGENT SET
Chemistry
92d
Cleared
Feb 21, 1991
TOTAL PROTEIN REAGENT SET
Chemistry
56d
Cleared
Feb 13, 1991
CREATININE (RATE) REAGENT SET
Chemistry
61d
Cleared
Feb 13, 1991
KINETIC ALKALINE PHOSPHATASE DETERMINATION
Chemistry
57d
Cleared
Jan 31, 1991
KINETIC AMYLASE DETERMINATION
Chemistry
44d
Cleared
Jan 30, 1991
GAMMA-GLUTAMYL TRANSFERASE DETERMINATION
Chemistry
43d
Cleared
Jan 17, 1991
CREATINE KINASE UV REAGENT SET
Chemistry
35d
Cleared
Jun 22, 1987
ULTRA-VIOLET BUN REAGENT KIT (RATE)
Chemistry
63d
Cleared
Jun 04, 1987
ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)
Chemistry
29d
Cleared
Jun 03, 1987
ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
Chemistry
28d
Cleared
May 26, 1987
ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)
Chemistry
20d
Cleared
May 12, 1987
GLUCOSE ENZYME - COLOR REAGENT SET
Chemistry
14d
Cleared
May 12, 1987
COLORIMETRIC BUN REAGENT KIT
Chemistry
14d
Cleared
Apr 29, 1987
ULTRA-VIOLET GLUCOSE REAGENT KIT
Chemistry
16d
Cleared
Apr 22, 1987
COLORIMETRIC URIC ACID REAGENT SET
Chemistry
15d
Cleared
Apr 13, 1987
CHOLESTEROL DETERMINATION
Chemistry
13d
Cleared
Apr 07, 1987
TRIGLYCERIDES DETERMINATION
Chemistry
18d