Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostics Biochem Canada, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
161 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT | Diagnostics Biochem Canada, Inc. | 2003-08-18 | 161 | 0 |
| K014120 | TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) | Diagnostics Biochem Canada, Inc. | 2002-02-08 | 53 | 0 |
| K864966 | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE | Diagnostics Biochem Canada, Inc. | 1987-01-09 | 18 | 0 |
| K832297 | HYDROXYPROGESTERONE-17 | Diagnostics Biochem Canada, Inc. | 1983-09-01 | 50 | 0 |
| K801729 | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT | Diagnostics Biochem Canada, Inc. | 1980-10-31 | 99 | 0 |
| K781310 | HUMAN CHORIONIC GONADO.-BETA RIA KIT | Diagnostics Biochem Canada, Inc. | 1978-08-31 | 31 | 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