510(k) K061508 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
OSOM INFLUENZA A&B TEST
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Jun 12, 2006 |
| Received | Jun 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061508
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.