FDA 510(k) Application Details - K002418

Device Classification Name	Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.   More FDA Info for this Device
510(K) Number	K002418
Device Name	Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Applicant	BRANAN MEDICAL CORPORATION 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	862.3640   More FDA Info for this Regulation Number
Classification Product Code	DOE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2000
Decision Date	11/22/2000
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