FDA 510(k) Application Details - K061257

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K061257
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	AMERITEK USA, INC. 125 130 ST. SE, #200 EVERETT, WA 98208 US Other 510(k) Applications for this Company
Contact	K C YEE Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	JHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2006
Decision Date	05/04/2007
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