FDA 510(k) Application Details - K082099

Device Classification Name	Electrode, Ion-Specific, Chloride   More FDA Info for this Device
510(K) Number	K082099
Device Name	Electrode, Ion-Specific, Chloride
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. 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	862.1170   More FDA Info for this Regulation Number
Classification Product Code	CGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2008
Decision Date	08/21/2008
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