510(k) K011163 ยท JXN Enzyme Immunoassay, Propoxyphene
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
| Applicant | Syva Co., Dade Behring, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, May 10, 2001 |
| Received | Apr 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011163
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.