510(k) K011684 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 30, 2001 |
| Received | May 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011684
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.