FDA 510(k) Application Details - K112449

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K112449
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Tianjin New Bay Bioresearch Co., Ltd. 5230 VIA PRIMARIA YORBA LINDA, CA 92886 US Other 510(k) Applications for this Company
Contact	HANN-PING WANG Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	LCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2011
Decision Date	09/24/2012
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