510(k) K895571 ยท LAN Enzyme Immunoassay, N-Acetylprocainamide
N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT
| Applicant | Tudor Laboratories, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Oct 25, 1989 |
| Received | Sep 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895571
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.