510(k) K944231 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 2, 1994 |
| Received | Aug 31, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944231
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.