510(k) K951709 ยท LSR Reagent, Borrelia Serological Reagent
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
| Applicant | Mardx Diagnostics, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 7, 1996 |
| Received | Apr 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951709
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.