VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II— 510(k) K142595
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K142595 for VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II, Substantially Equivalent on 2015-06-04. Applicant: Ortho Clinical Diagnostics.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code PDJ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.