VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV— 510(k) K062285
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K062285 for VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV, Substantially Equivalent on 2006-12-22. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code JXM
- Device class
- Class 2
- Regulation
- 21 CFR 862.3170
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code JXM
view allMore 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.