510(k) K111363 ยท JXN Enzyme Immunoassay, Propoxyphene
PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
| Applicant | Medica Corp., Bedford MA, US |
| Decision | Substantially Equivalent, Dec 6, 2011 |
| Received | May 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111363
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.