Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iquum, Inc. — 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) |
|---|---|---|---|---|---|
| K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the c | Iquum, Inc. | 2016-07-25 | 227 | 0 |
| K141338 | LIAT STREP A ASSAY | Iquum, Inc. | 2014-11-04 | 167 | 0 |
| K111387 | LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER | Iquum, Inc. | 2011-08-04 | 79 | 2 |
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