FDA 510(k) Application Details - K030860

Device Classification Name	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine   More FDA Info for this Device
510(K) Number	K030860
Device Name	Enzyme Immunoassay, Non-Radiolabeled, Total 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	862.1700   More FDA Info for this Regulation Number
Classification Product Code	KLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2003
Decision Date	08/22/2003
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