510(k) K062460 ยท DJG Enzyme Immunoassay, Opiates
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 15, 2006 |
| Received | Aug 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062460
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2025 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. Open, Classified |
DJG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.