VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III— 510(k) K043386
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K043386 for VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III, Substantially Equivalent on 2005-02-07. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code LEH
- Device class
- Class 2
- Regulation
- 21 CFR 862.3950
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code LEH
view all- K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
- K160202 — Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
- K152245 — ONLINE TDM Vancomycin Gen.3
- K123947 — ARCHITECT IVANCOMYCIN
- K072036 — ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
More clearances from Ortho-Clinical Diagnostics, Inc.
view all- K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
- DEN210038 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
- DEN210040 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
- K210858 — VITROS Chemistry Products PHBR Slides
- K191316 — VITROS XT Chemistry Products ALB-TP Slides
Recalls naming K043386
K-number listed on FDA's recall record- Z-1833-2025 — ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
- Z-1887-2017 — 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 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043386.
Data sourced from openFDA. This site is unofficial and independent of the FDA.