510(k) K950829 ยท LSR Reagent, Borrelia Serological Reagent
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
| Applicant | Mardx Diagnostics, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 5, 1996 |
| Received | Feb 23, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950829
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.