FDA 510(k) Application Details - K171168

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K171168
Device Name	Calibrator, Secondary
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	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2017
Decision Date	05/16/2017
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