510(k) K031565 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
XPECT INFLUENZA A/B
| Applicant | Remel, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Jul 17, 2003 |
| Received | May 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031565
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.