Biochemical Trade, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 20
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | November 21, 1994 |
| K910635 | TOTAL BILIRUBIN REAGENT SET | May 15, 1991 |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | February 27, 1991 |
| K905776 | ALBUMIN REAGENT SET | February 26, 1991 |
| K905790 | TOTAL PROTEIN REAGENT SET | February 21, 1991 |
| K905650 | KINETIC ALKALINE PHOSPHATASE DETERMINATION | February 13, 1991 |
| K905619 | CREATININE (RATE) REAGENT SET | February 13, 1991 |
| K905651 | KINETIC AMYLASE DETERMINATION | January 31, 1991 |
| K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION | January 30, 1991 |
| K905588 | CREATINE KINASE UV REAGENT SET | January 17, 1991 |
| K871547 | ULTRA-VIOLET BUN REAGENT KIT (RATE) | June 22, 1987 |
| K871780 | ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) | June 4, 1987 |
| K871781 | ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET | June 3, 1987 |
| K871782 | ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) | May 26, 1987 |
| K871651 | COLORIMETRIC BUN REAGENT KIT | May 12, 1987 |
| K871650 | GLUCOSE ENZYME - COLOR REAGENT SET | May 12, 1987 |
| K871456 | ULTRA-VIOLET GLUCOSE REAGENT KIT | April 29, 1987 |
| K871417 | COLORIMETRIC URIC ACID REAGENT SET | April 22, 1987 |
| K871260 | CHOLESTEROL DETERMINATION | April 13, 1987 |
| K871122 | TRIGLYCERIDES DETERMINATION | April 7, 1987 |