510(k) K964116 ยท LBZ Enzyme Immunoassay, Quinidine
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 24, 1996 |
| Received | Oct 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964116
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.