VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002— 510(k) K093611
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K093611 for VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002, Substantially Equivalent on 2010-04-15. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Device name as filed
- VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code KHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code KHS
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.