510(k) K894293 ยท LSR Reagent, Borrelia Serological Reagent
MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
| Applicant | Mardx Diagnostics, Inc., Scotch Plains NJ, US |
| Decision | Substantially Equivalent, Aug 21, 1989 |
| Received | Jun 23, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894293
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.