Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dynagen, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
259 daysmedian FDA review time
259 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963733 | NICCHECK I | Dynagen, Inc. | 1996-12-13 | 88 | 0 |
| K943049 | MYCOAKT M. AVIUM CULTURE ID KIT | Dynagen, Inc. | 1995-03-13 | 259 | 0 |
| K943051 | MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT | Dynagen, Inc. | 1995-03-13 | 259 | 0 |
| K943050 | MYCOAKT M KANSASII CULTURE ID KIT | Dynagen, Inc. | 1995-03-13 | 259 | 0 |
| K931105 | PROCHECK(TM) BLIND PERFORMANCE SPECIMENS | Dynagen, Inc. | 1993-04-21 | 49 | 0 |
| K912888 | URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL | Dynagen, Inc. | 1992-02-24 | 238 | 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