Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applications Lab — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
20 daysmedian FDA review time
29 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850587 | SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN | Applications Lab | 1985-03-14 | 29 | 0 |
| K850586 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M | Applications Lab | 1985-03-14 | 29 | 0 |
| K850603 | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN | Applications Lab | 1985-03-05 | 18 | 0 |
| K850589 | SPQ TEST SYSTEM FOR TRANSFERRIN | Applications Lab | 1985-03-05 | 20 | 0 |
| K850584 | SPQ TEST SYSTEM FOR HAPTOGLOBIN | Applications Lab | 1985-03-05 | 20 | 0 |
| K850588 | SPQ TEST SYSTEM FOR COMPLEMENT C3 | Applications Lab | 1985-03-05 | 20 | 0 |
| K850585 | SPQ TEST SYSTEM FOR COMPLEMENT C4 | Applications Lab | 1985-03-01 | 16 | 0 |
| K850583 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G | Applications Lab | 1985-03-01 | 16 | 0 |
| K850582 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A | Applications Lab | 1985-03-01 | 16 | 0 |
| K850590 | SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN | Applications Lab | 1985-03-01 | 16 | 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