Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biochemical Diagnostic, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
364 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID C | Biochemical Diagnostic, Inc. | 2012-07-03 | 81 | 0 |
| K050328 | PREGNANCY-SKREEN | Biochemical Diagnostic, Inc. | 2005-03-29 | 48 | 2 |
| K925586 | DETECTABUSE(TM) | Biochemical Diagnostic, Inc. | 1992-12-28 | 54 | 0 |
| K904181 | ANTI-GBM ANTIBODIES QUANTITATIVE KIT | Biochemical Diagnostic, Inc. | 1991-09-10 | 364 | 0 |
| K841831 | CANNU-SKREEN-PRELIMINARY | Biochemical Diagnostic, Inc. | 1984-07-06 | 64 | 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