510(k) K971716 ยท LAR Enzyme Immunoassay, Procainamide
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 27, 1997 |
| Received | May 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971716
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.