510(k) K142595

VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II by Ortho Clinical Diagnostics — Product Code PDJ

K142595 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II". The FDA issued a decision of Substantially Equivalent on June 4, 2015. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.