510(k) K062285 ยท JXM Enzyme Immunoassay, Benzodiazepine
VITROS CHEMISTRY PRODUCTS BENZ 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, Dec 22, 2006 |
| Received | Aug 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062285
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.