Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biochemical Trade, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
92 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | Biochemical Trade, Inc. | 1994-11-21 | 151 | 1 |
| K910635 | TOTAL BILIRUBIN REAGENT SET | Biochemical Trade, Inc. | 1991-05-15 | 92 | 0 |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | Biochemical Trade, Inc. | 1991-02-27 | 35 | 0 |
| K905776 | ALBUMIN REAGENT SET | Biochemical Trade, Inc. | 1991-02-26 | 61 | 0 |
| K905790 | TOTAL PROTEIN REAGENT SET | Biochemical Trade, Inc. | 1991-02-21 | 56 | 0 |
| K905650 | KINETIC ALKALINE PHOSPHATASE DETERMINATION | Biochemical Trade, Inc. | 1991-02-13 | 57 | 0 |
| K905619 | CREATININE (RATE) REAGENT SET | Biochemical Trade, Inc. | 1991-02-13 | 61 | 0 |
| K905651 | KINETIC AMYLASE DETERMINATION | Biochemical Trade, Inc. | 1991-01-31 | 44 | 0 |
| K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION | Biochemical Trade, Inc. | 1991-01-30 | 43 | 0 |
| K905588 | CREATINE KINASE UV REAGENT SET | Biochemical Trade, Inc. | 1991-01-17 | 35 | 0 |
| K871547 | ULTRA-VIOLET BUN REAGENT KIT (RATE) | Biochemical Trade, Inc. | 1987-06-22 | 63 | 0 |
| K871780 | ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) | Biochemical Trade, Inc. | 1987-06-04 | 29 | 0 |
| K871781 | ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET | Biochemical Trade, Inc. | 1987-06-03 | 28 | 0 |
| K871782 | ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) | Biochemical Trade, Inc. | 1987-05-26 | 20 | 0 |
| K871651 | COLORIMETRIC BUN REAGENT KIT | Biochemical Trade, Inc. | 1987-05-12 | 14 | 0 |
| K871650 | GLUCOSE ENZYME - COLOR REAGENT SET | Biochemical Trade, Inc. | 1987-05-12 | 14 | 0 |
| K871456 | ULTRA-VIOLET GLUCOSE REAGENT KIT | Biochemical Trade, Inc. | 1987-04-29 | 16 | 0 |
| K871417 | COLORIMETRIC URIC ACID REAGENT SET | Biochemical Trade, Inc. | 1987-04-22 | 15 | 0 |
| K871260 | CHOLESTEROL DETERMINATION | Biochemical Trade, Inc. | 1987-04-13 | 13 | 0 |
| K871122 | TRIGLYCERIDES DETERMINATION | Biochemical Trade, Inc. | 1987-04-07 | 18 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda