510(k) K981913 ยท LSR Reagent, Borrelia Serological Reagent
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
| Applicant | Chembio Diagnostic Systems, Inc., Stony Brook NY, US |
| Decision | Substantially Equivalent, Feb 12, 1999 |
| Received | Jun 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981913
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.