510(k) K971007 ยท LSR Reagent, Borrelia Serological Reagent
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
| Applicant | Mrl Diagnostics, Cypress CA, US |
| Decision | Substantially Equivalent, Jun 1, 1998 |
| Received | Mar 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971007
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.