510(k) K945195 ยท JXN Enzyme Immunoassay, Propoxyphene
ABUSCREEN ONLINE PROPOXPHENE
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 9, 1994 |
| Received | Oct 24, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945195
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.