FDA 510(k) Application Details - K072500

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K072500
Device Name	System, Test, Human Chorionic Gonadotropin
Applicant	Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE YARDLEY, PA 19067 US Other 510(k) Applications for this Company
Contact	HOWARD MANN Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	DHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2007
Decision Date	04/21/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review