510(k) K981651 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
AB FLU OIA
| Applicant | Biostar, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Nov 25, 1998 |
| Received | May 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981651
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.