510(k) K991185 ยท LSR Reagent, Borrelia Serological Reagent
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Sep 3, 1999 |
| Received | Apr 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991185
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.