510(k) K853547 ยท LAN Enzyme Immunoassay, N-Acetylprocainamide
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I
| Applicant | American Dade, Santa Ana CA, US |
| Decision | Substantially Equivalent, Sep 16, 1985 |
| Received | Aug 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853547
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.