FDA 510(k) Application Details - K142595

Device Classification Name	More FDA Info for this Device
510(K) Number	K142595
Device Name	VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
Applicant	ORTHO CLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE ROCHESTER, NY 14626 US Other 510(k) Applications for this Company
Contact	Bradley P Boyer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2014
Decision Date	06/04/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review