510(k) K900338 ยท GMQ Antigens, Nontreponemal, All
VISUWELL(R) REAGIN TEST (MODIFICATION)
| Applicant | Adi Diagnostics, Inc., Rexdale, Ontario, CA |
| Decision | Substantially Equivalent, Apr 10, 1990 |
| Received | Jan 23, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900338
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.