FDA 510(k) Application Details - K063164

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K063164
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	MICHAEL M BYRNE Other 510(k) Applications for this Contact
Regulation Number	862.3870   More FDA Info for this Regulation Number
Classification Product Code	LDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2006
Decision Date	12/28/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review