Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rapid Diagnostics, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033566 | MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07R | Rapid Diagnostics, Inc. | 2004-05-17 | 187 | 0 |
| K020716 | RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND | Rapid Diagnostics, Inc. | 2002-05-06 | 62 | 0 |
| K003809 | RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS | Rapid Diagnostics, Inc. | 2001-04-20 | 133 | 0 |
| K981770 | RAPIDHCG PREGNANCY TEST | Rapid Diagnostics, Inc. | 1998-06-05 | 17 | 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