510(k) K043386 ยท LEH Radioimmunoassay, Vancomycin
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 7, 2005 |
| Received | Dec 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043386
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT. Open, Classified |
LEH | None listed |
| Feb 21, 2017 | Ortho-Clinical Diagnostics VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5 Terminated |
LEH | None listed |
| Nov 18, 2005 | Ortho-Clinical Diagnostics VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626 Terminated |
LEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.