510(k) K894609 ยท LSR Reagent, Borrelia Serological Reagent
MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
| Applicant | Mardx, Inc., Scotch Plains NJ, US |
| Decision | Substantially Equivalent, Sep 19, 1989 |
| Received | Jul 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894609
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.