Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zymetx, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984596 | VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTI | Zymetx, Inc. | 1999-03-04 | 66 | 0 |
| K982429 | ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES | Zymetx, Inc. | 1998-08-25 | 43 | 0 |
| K971494 | VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUS | Zymetx, Inc. | 1997-09-10 | 139 | 0 |
| K950838 | VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAI | Zymetx, Inc. | 1996-06-17 | 479 | 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