510(k) K944606 ยท DJG Enzyme Immunoassay, Opiates
CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS
| Applicant | Beckman-Diagnostic Systems Group, Brea CA, US |
| Decision | Substantially Equivalent, Nov 30, 1994 |
| Received | Sep 19, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944606
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.