FDA 510(k) Application Details - K053452

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K053452
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	BIO FOCUS CO., LT. 251E. REDONDO BEACH BLVD. GARDENA, CA 90248 US Other 510(k) Applications for this Company
Contact	LAUREN HONG 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	12/12/2005
Decision Date	05/25/2006
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