FDA 510(k) Application Details - K131515

Device Classification Name	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine   More FDA Info for this Device
510(K) Number	K131515
Device Name	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Applicant	ALFA WASSERMANN 4 Henderson Drive Caldwell, NJ 07006 US Other 510(k) Applications for this Company
Contact	HYMAN KATZ, PH.D. 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	05/28/2013
Decision Date	08/14/2013
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