FDA 510(k) Application Details - K974027

Device Classification Name	Radioimmunoassay, Total Triiodothyronine   More FDA Info for this Device
510(K) Number	K974027
Device Name	Radioimmunoassay, Total Triiodothyronine
Applicant	ALFA BIOTECH (UK) LTD. 4 SPRING LAKES ESTATE, DEADBROOK LANE ALDERSHOT GU12 4UH GB Other 510(k) Applications for this Company
Contact	M. JOHN TAYLOR Other 510(k) Applications for this Contact
Regulation Number	862.1710   More FDA Info for this Regulation Number
Classification Product Code	CDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/1997
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	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review