FDA 510(k) Application Details - K123379

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K123379
Device Name	Radioimmunoassay, Free Thyroxine
Applicant	ABBOTT LABORATORIES 100 ABBOTT PARK RD. ABBOTT PARK, IL 60064-3500 US Other 510(k) Applications for this Company
Contact	JACEK GORZOWSKI 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	11/01/2012
Decision Date	11/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review