510(k) K892206 ยท LSR Reagent, Borrelia Serological Reagent
MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
| Applicant | Mardx Diagnostics, Inc., Scotch Plains NJ, US |
| Decision | Substantially Equivalent, Aug 15, 1989 |
| Received | Apr 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892206
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.