FDA 510(k) Application Details - K043231

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K043231
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	MIZUHO USA, INC. 12131 COMMUNITY RD. POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	BENEDICT ZIN 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	11/22/2004
Decision Date	04/25/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review