FDA 510(k) Application Details - K010734

Device Classification Name	Thin Layer Chroomatography, Tricyclic Antidepressant Drugs   More FDA Info for this Device
510(K) Number	K010734
Device Name	Thin Layer Chroomatography, Tricyclic Antidepressant Drugs
Applicant	BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	RAPHAEL WONG Other 510(k) Applications for this Contact
Regulation Number	862.3910   More FDA Info for this Regulation Number
Classification Product Code	MLK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2001
Decision Date	07/30/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review