Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3M Diagnostic Systems, 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) |
|---|---|---|---|---|---|
| K913054 | 3M ANTI-CARDIOLIPIN FAST(TM) TEST | 3M Diagnostic Systems, Inc. | 1991-11-27 | 141 | 0 |
| K913653 | 3M ANTI-DSDNA FAST TEST | 3M Diagnostic Systems, Inc. | 1991-11-07 | 83 | 0 |
| K913892 | FASTTECH SYSTEM II | 3M Diagnostic Systems, Inc. | 1991-10-02 | 33 | 0 |
| K911496 | FASTTECH SYSTEM 1 | 3M Diagnostic Systems, Inc. | 1991-06-24 | 81 | 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