FDA 510(k) Application Details - K984288

Device Classification Name	Enzyme Immunoassay, Phenobarbital   More FDA Info for this Device
510(K) Number	K984288
Device Name	Enzyme Immunoassay, Phenobarbital
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	MARLENE A SHULMAN Other 510(k) Applications for this Contact
Regulation Number	862.3660   More FDA Info for this Regulation Number
Classification Product Code	DLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/1998
Decision Date	01/26/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review