510(k) K911145 ยท LSR Reagent, Borrelia Serological Reagent
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
| Applicant | Medical Diagnostic Technologies, Inc., Augusta GA, US |
| Decision | Substantially Equivalent, May 10, 1991 |
| Received | Mar 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911145
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.