FDA 510(k) Application Details - K974508

Device Classification Name	Radioimmunoassay, Luteinizing Hormone   More FDA Info for this Device
510(K) Number	K974508
Device Name	Radioimmunoassay, Luteinizing Hormone
Applicant	AMERITEK, INC. 7030 35TH AVE., N.E. SEATTLE, WA 98115 US Other 510(k) Applications for this Company
Contact	KUO CHIANG YEE Other 510(k) Applications for this Contact
Regulation Number	862.1485   More FDA Info for this Regulation Number
Classification Product Code	CEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/1997
Decision Date	02/02/1998
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