510(k) K991063 ยท LSR Reagent, Borrelia Serological Reagent
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
| Applicant | Immunetics, Inc., Cambridge, MA, US |
| Decision | Substantially Equivalent, Sep 21, 1999 |
| Received | Mar 31, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991063
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.