FDA 510(k) Application Details - K123271

Device Classification Name	Enzyme Immunoassay, Phenobarbital   More FDA Info for this Device
510(K) Number	K123271
Device Name	Enzyme Immunoassay, Phenobarbital
Applicant	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	KAREN LEE 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	10/19/2012
Decision Date	04/26/2013
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