Medical Device Manufacturer · US , Miami , FL

Biochemical Trade, Inc.

20 submissions · 20 cleared · Since 1987
20
Total
20
Cleared
0
Denied

Biochemical Trade, Inc. — FDA 510(k) Submissions

Biochemical Trade, Inc. has submitted 20 FDA 510(k) premarket notifications since 1987, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include U.v. Method, Cpk Isoenzymes, Berthelot Indophenol, Urea Nitrogen, Phosphomolybdate (colorimetric), Inorganic Phosphorus, Nadh Oxidation/nad Reduction, Ast/sgot, Diazo Colorimetry, Bilirubin . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
CREATINE KINASE MB DETERMINATION (UV)
K942958 · JHW U.v. Method, Cpk Isoenzymes · Chemistry
Nov 1994 151d
TOTAL BILIRUBIN REAGENT SET
K910635 · CIG Diazo Colorimetry, Bilirubin · Chemistry
May 1991 92d
PHOSPHORUS (INORGANIC) TEST SYSTEM
K910296 · CEO Phosphomolybdate... · Toxicology
Feb 1991 35d
ALBUMIN REAGENT SET
K905776 · CJW Bromcresol Purple... · Toxicology
Feb 1991 61d
TOTAL PROTEIN REAGENT SET
K905790 · CEK Biuret (colorimetric),... · Chemistry
Feb 1991 56d
CREATININE (RATE) REAGENT SET
K905619 · CGX Alkaline Picrate,... · Chemistry
Feb 1991 61d
KINETIC ALKALINE PHOSPHATASE DETERMINATION
K905650 · CJE Nitrophenylphosphate,... · Chemistry
Feb 1991 57d
KINETIC AMYLASE DETERMINATION
K905651 · JFJ Catalytic Methods, Amylase · Chemistry
Jan 1991 44d
GAMMA-GLUTAMYL TRANSFERASE DETERMINATION
K905649 · JQB Kinetic Method,... · Chemistry
Jan 1991 43d
CREATINE KINASE UV REAGENT SET
K905588 · JHW U.v. Method, Cpk Isoenzymes · Chemistry
Jan 1991 35d
ULTRA-VIOLET BUN REAGENT KIT (RATE)
K871547 · CDQ Urease And Glutamic... · Chemistry
Jun 1987 63d
ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)
K871780 · CIT Nadh Oxidation/nad... · Chemistry
Jun 1987 29d
ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
K871781 · CFJ Nad Reduction/nadh... · Chemistry
Jun 1987 28d
ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)
K871782 · CKA Nadh Oxidation/nad... · Chemistry
May 1987 20d
GLUCOSE ENZYME - COLOR REAGENT SET
K871650 · CGA Glucose Oxidase, Glucose · Chemistry
May 1987 14d
COLORIMETRIC BUN REAGENT KIT
K871651 · CDL Berthelot Indophenol,... · Chemistry
May 1987 14d
ULTRA-VIOLET GLUCOSE REAGENT KIT
K871456 · CFR Hexokinase, Glucose · Chemistry
Apr 1987 16d
COLORIMETRIC URIC ACID REAGENT SET
K871417 · KNK Acid, Uric, Uricase... · Chemistry
Apr 1987 15d
CHOLESTEROL DETERMINATION
K871260 · CHH Enzymatic... · Chemistry
Apr 1987 13d
TRIGLYCERIDES DETERMINATION
K871122 · CDT Lipase... · Chemistry
Apr 1987 18d
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