510(k) K011620 ยท LAN Enzyme Immunoassay, N-Acetylprocainamide
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
| Applicant | Syva Co., Dade Behring, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jun 18, 2001 |
| Received | May 25, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011620
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.