510(k) K895292 ยท LSR Reagent, Borrelia Serological Reagent
LYME IGG ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Dec 13, 1989 |
| Received | Aug 25, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895292
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.