FDA 510(k) Application Details - K050024

Device Classification Name	Enzyme Immunoassay, Barbiturate   More FDA Info for this Device
510(K) Number	K050024
Device Name	Enzyme Immunoassay, Barbiturate
Applicant	Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE YARDLEY, PA 19087 US Other 510(k) Applications for this Company
Contact	HOWARD K MANN Other 510(k) Applications for this Contact
Regulation Number	862.3150   More FDA Info for this Regulation Number
Classification Product Code	DIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2005
Decision Date	11/17/2005
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