510(k) K911599 ยท LSR Reagent, Borrelia Serological Reagent
IMMUNOWELL LYME (P39 RECOMBINANT) TEST
| Applicant | General Biometrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 30, 1991 |
| Received | Apr 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911599
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.