510(k) K900206 ยท LSR Reagent, Borrelia Serological Reagent
LYME DISEASE IGM ELISA
| Applicant | Hillcrest Biologicals, Cypress CA, US |
| Decision | Substantially Equivalent, Jun 28, 1991 |
| Received | Jan 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900206
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.