FDA 510(k) Application Details - K020548

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K020548
Device Name	Radioimmunoassay, Free Thyroxine
Applicant	MONOBIND 729 WEST 16TH ST., C-4 COSTA MESA, CA 92627 US Other 510(k) Applications for this Company
Contact	JAY SINGH 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	02/19/2002
Decision Date	04/05/2002
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