510(k) K885298 ยท GMP Antisera, Control For Nontreponemal Tests
VISUWELL REAGIN TEST 960 TEST KIT
| Applicant | Allelix Diagnostics, Inc., Canada L4v 1p1, CA |
| Decision | Substantially Equivalent, Mar 15, 1989 |
| Received | Dec 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885298
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.