510(k) K062637 ยท DJR Enzyme Immunoassay, Methadone
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 22, 2006 |
| Received | Sep 5, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062637
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.