510(k) K883767 ยท LSR Reagent, Borrelia Serological Reagent
LYME DISEASE IFA (IGM)
| Applicant | Hillcrest Biologicals, Cypress CA, US |
| Decision | Substantially Equivalent, Mar 15, 1989 |
| Received | Sep 6, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883767
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.