FDA 510(k) Application Details - K161140

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K161140
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	ORTHO-CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DRIVE ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	MARLENE HANNA Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2016
Decision Date	05/20/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review