510(k) K984138 ยท LSR Reagent, Borrelia Serological Reagent
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Mar 23, 1999 |
| Received | Nov 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984138
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.