FDA 510(k) Application Details - K122633

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K122633
Device Name	Enzyme Immunoassay, Cannabinoids
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	862.3870   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	08/29/2012
Decision Date	02/07/2013
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