510(k) K993048 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 20, 1999 |
| Received | Sep 10, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993048
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.