K142595

Substantially Equivalent

VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II

Applicant: Ortho Clinical Diagnostics
Product code: PDJ
Advisory panel: Clinical Chemistry
Date received: 2014-09-15
Decision date: 2015-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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