510(k) K983605 ยท LSR Reagent, Borrelia Serological Reagent
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
| Applicant | Columbia Bioscience, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Dec 16, 1998 |
| Received | Oct 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983605
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.