Company ยท US
Biochemical Trade, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1994. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHW | U.V. Method, Cpk Isoenzymes | 2 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 1994 | K942958 | CREATINE KINASE MB DETERMINATION (UV) Biochemical Trade, Inc. | JHW |
| May 15, 1991 | K910635 | TOTAL BILIRUBIN REAGENT SET Biochemical Trade, Inc. | CIG |
| Feb 27, 1991 | K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM Biochemical Trade, Inc. | CEO |
| Feb 26, 1991 | K905776 | ALBUMIN REAGENT SET Biochemical Trade, Inc. | CJW |
| Feb 21, 1991 | K905790 | TOTAL PROTEIN REAGENT SET Biochemical Trade, Inc. | CEK |
| Feb 13, 1991 | K905650 | KINETIC ALKALINE PHOSPHATASE DETERMINATION Biochemical Trade, Inc. | CJE |
| Feb 13, 1991 | K905619 | CREATININE (RATE) REAGENT SET Biochemical Trade, Inc. | CGX |
| Jan 31, 1991 | K905651 | KINETIC AMYLASE DETERMINATION Biochemical Trade, Inc. | JFJ |
| Jan 30, 1991 | K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION Biochemical Trade, Inc. | JQB |
| Jan 17, 1991 | K905588 | CREATINE KINASE UV REAGENT SET Biochemical Trade, Inc. | JHW |
| Jun 22, 1987 | K871547 | ULTRA-VIOLET BUN REAGENT KIT (RATE) Biochemical Trade, Inc. | CDQ |
| Jun 4, 1987 | K871780 | ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) Biochemical Trade, Inc. | CIT |
| Jun 3, 1987 | K871781 | ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET Biochemical Trade, Inc. | CFJ |
| May 26, 1987 | K871782 | ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) Biochemical Trade, Inc. | CKA |
| May 12, 1987 | K871651 | COLORIMETRIC BUN REAGENT KIT Biochemical Trade, Inc. | CDL |
| May 12, 1987 | K871650 | GLUCOSE ENZYME - COLOR REAGENT SET Biochemical Trade, Inc. | CGA |
| Apr 29, 1987 | K871456 | ULTRA-VIOLET GLUCOSE REAGENT KIT Biochemical Trade, Inc. | CFR |
| Apr 22, 1987 | K871417 | COLORIMETRIC URIC ACID REAGENT SET Biochemical Trade, Inc. | KNK |
| Apr 13, 1987 | K871260 | CHOLESTEROL DETERMINATION Biochemical Trade, Inc. | CHH |
| Apr 7, 1987 | K871122 | TRIGLYCERIDES DETERMINATION Biochemical Trade, Inc. | CDT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||