FDA 510(k) Application Details - K063144

Device Classification Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use   More FDA Info for this Device
510(K) Number	K063144
Device Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	SARAH C PARSONS Other 510(k) Applications for this Contact
Regulation Number	862.2160   More FDA Info for this Regulation Number
Classification Product Code	JJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2006
Decision Date	11/13/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review