510(k) K903013 ยท LSR Reagent, Borrelia Serological Reagent
LYME IGM ELISA TEST
| Applicant | Gull Laboratories, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jun 21, 1991 |
| Received | Jul 11, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903013
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.