510(k) K982328 ยท CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jan 29, 1999 |
| Received | Jul 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982328
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.