510(k) K896378 ยท LSR Reagent, Borrelia Serological Reagent
LYME-CHECK(TM) TEST KIT
| Applicant | Diagnostic Technology, Inc., Hauppauge NY, US |
| Decision | Substantially Equivalent, Nov 5, 1991 |
| Received | Nov 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896378
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.