Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Instrumentation Laboratory — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233790 | ACL TOP 970 CL | Instrumentation Laboratory | 2023-12-29 | 31 | 0 |
| K133582 | HEMOSIL D-DIMER HS 500 CONTROL | Instrumentation Laboratory | 2014-08-15 | 267 | 0 |
| K073042 | HEMOSIL D-DIMER | Instrumentation Laboratory | 2008-07-31 | 276 | 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