510(k) K032564 ยท LAN Enzyme Immunoassay, N-Acetylprocainamide
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
| Applicant | Dade Behring, Inc., P.O. Box 6101, Newark DE, US |
| Decision | Substantially Equivalent, Oct 31, 2003 |
| Received | Aug 20, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032564
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.