FDA 510(k) Application Details - K122752

Device Classification Name	Enzyme Immunoassay, Propoxyphene   More FDA Info for this Device
510(K) Number	K122752
Device Name	Enzyme Immunoassay, Propoxyphene
Applicant	BRANAN MEDICAL CORP. 140 Technology Dr Ste 400 IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	Olivia Chan Other 510(k) Applications for this Contact
Regulation Number	862.3700   More FDA Info for this Regulation Number
Classification Product Code	JXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2012
Decision Date	01/30/2013
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