510(k) K062123 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 16, 2006 |
| Received | Jul 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062123
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products COCM Reagent Terminated |
DIO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.