510(k) K900196 ยท LSR Reagent, Borrelia Serological Reagent
LYME IGM ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, May 2, 1990 |
| Received | Jan 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900196
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.