Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lab Ability, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
91 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833407 | SELECTO-DISC NOVOBIOCIN 5UG | Lab Ability, Inc. | 1983-12-30 | 91 | 0 |
| K832436 | SELECTRO-DISC | Lab Ability, Inc. | 1983-09-26 | 63 | 0 |
| K830133 | Q-CHECK CULTI-LOOPS | Lab Ability, Inc. | 1983-02-09 | 27 | 0 |
| K830134 | Q-CHECK REAGENT STANDARDS | Lab Ability, Inc. | 1983-01-09 | 0 | 0 |
| K813191 | SHIGELLA SERA-CHEK | Lab Ability, Inc. | 1981-12-03 | 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