510(k) K911627 ยท LSR Reagent, Borrelia Serological Reagent
IMMUNODOT BORRELIA (LYME) TEST
| Applicant | General Biometrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 8, 1992 |
| Received | Apr 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911627
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.