510(k) K910230 ยท LSR Reagent, Borrelia Serological Reagent
LYME-SPOT IF KIT
| Applicant | Vitek Systems, Inc., Hazelwood MI, US |
| Decision | Substantially Equivalent, Aug 30, 1991 |
| Received | Jan 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910230
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.