510(k) K894410 ยท LSR Reagent, Borrelia Serological Reagent
IMMUNODOT LYME TEST
| Applicant | General Biometrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 30, 1989 |
| Received | Jul 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894410
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.