510(k) K875286 ยท LSR Reagent, Borrelia Serological Reagent
LYME STAT TEST KIT
| Applicant | Whittaker Bioproducts, Inc., Walkersville MD, US |
| Decision | Substantially Equivalent, Mar 30, 1988 |
| Received | Dec 29, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K875286
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.