FDA 510(k) Application Details - K093611

Device Classification Name	Enzymatic, Carbon-Dioxide   More FDA Info for this Device
510(K) Number	K093611
Device Name	Enzymatic, Carbon-Dioxide
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. MC 00882 ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	MARLENE A HANNA Other 510(k) Applications for this Contact
Regulation Number	862.1160   More FDA Info for this Regulation Number
Classification Product Code	KHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2009
Decision Date	04/15/2010
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