Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Instrumentation Laboratory Company · 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) |
|---|---|---|---|---|---|
| K230852 | HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company | 2023-12-13 | 260 | 0 |
| K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | 2023-08-10 | 251 | 2 |
| K231031 | ACL TOP Family 70 Series | Instrumentation Laboratory Company | 2023-06-21 | 71 | 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