510(k) K860140 ยท LAN Enzyme Immunoassay, N-Acetylprocainamide
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
| Applicant | American Dade, Santa Ana CA, US |
| Decision | Substantially Equivalent, Feb 6, 1986 |
| Received | Jan 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860140
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.