FDA 510(k) Application Details - K070708

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K070708
Device Name	Radioimmunoassay, Free Thyroxine
Applicant	OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH LISMEEHAN, O'CALLAGHANS MILLS CO. CLARE IE Other 510(k) Applications for this Company
Contact	STEPHANIE G SCHWARTZ Other 510(k) Applications for this Contact
Regulation Number	862.1695   More FDA Info for this Regulation Number
Classification Product Code	CEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2007
Decision Date	08/21/2007
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