510(k) K945608 ยท DJG Enzyme Immunoassay, Opiates
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
| Applicant | Princeton BioMeditech Corp., Princeton NJ, US |
| Decision | Substantially Equivalent, Feb 10, 1995 |
| Received | Nov 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945608
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.