FDA 510(k) Application Details - K103484

Device Classification Name	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine   More FDA Info for this Device
510(K) Number	K103484
Device Name	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Applicant	WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. 940 WINTER STREET WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	SUSAN K HAMANN 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	11/26/2010
Decision Date	04/22/2011
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