Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pb 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) |
|---|---|---|---|---|---|
| K925703 | OPUS SEROLOGY CONTROLS | Pb Diagnostics, Inc. | 1993-04-08 | 147 | 0 |
| K921523 | OPUS(R) TOXO-G TEST SYSTEM | Pb Diagnostics, Inc. | 1992-09-14 | 167 | 0 |
| K915870 | OPUS RUBELLA TEST SYSTEM | Pb Diagnostics, Inc. | 1992-03-23 | 83 | 0 |
| K913080 | OPUS(R) ANTI CMV-M | Pb Diagnostics, Inc. | 1991-10-28 | 109 | 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