510(k) K980638 ยท GMP Antisera, Control For Nontreponemal Tests
ADI SYPHILIS RPR LIQUID CONTROLS
| Applicant | Ampcor Diagnostics, Inc., Bridgeport NJ, US |
| Decision | Substantially Equivalent, Jul 6, 1998 |
| Received | Feb 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980638
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.