510(k) K904652 ยท LSR Reagent, Borrelia Serological Reagent
LYME STAT M TEST KIT
| Applicant | Whittaker Bioproducts, Inc., Walkersville MD, US |
| Decision | Substantially Equivalent, Oct 21, 1991 |
| Received | Oct 15, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904652
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.