FDA 510(k) Application Details - K062285

Device Classification Name	Enzyme Immunoassay, Benzodiazipine   More FDA Info for this Device
510(K) Number	K062285
Device Name	Enzyme Immunoassay, Benzodiazipine
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	Darlene J Phillips Other 510(k) Applications for this Contact
Regulation Number	862.3170   More FDA Info for this Regulation Number
Classification Product Code	JXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2006
Decision Date	12/22/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review