FDA 510(k) Application Details - K980574

Device Classification Name	Radioimmunoassay, Thyroid-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K980574
Device Name	Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant	ALFA BIOTECH (UK) LTD. 4 SPRING LAKES ESTATE, DEADBROOK LANE ALDERSHOT GU12 4UH GB Other 510(k) Applications for this Company
Contact	M J TAYLOR Other 510(k) Applications for this Contact
Regulation Number	862.1690   More FDA Info for this Regulation Number
Classification Product Code	JLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/1998
Decision Date	03/24/1998
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