510(k) K885293 ยท LSR Reagent, Borrelia Serological Reagent
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
| Applicant | Medical Diagnostic Technologies, Inc., Augusta GA, US |
| Decision | Substantially Equivalent, Apr 10, 1989 |
| Received | Dec 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885293
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.