510(k) K871246 ยท LSR Reagent, Borrelia Serological Reagent
IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Aug 25, 1987 |
| Received | Mar 27, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871246
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.