FDA 510(k) Application Details - K112933

Device Classification Name	Immunochemical, Thyroglobulin Autoantibody   More FDA Info for this Device
510(K) Number	K112933
Device Name	Immunochemical, Thyroglobulin Autoantibody
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	GERALDINE L BAGLIEN Other 510(k) Applications for this Contact
Regulation Number	866.5870   More FDA Info for this Regulation Number
Classification Product Code	JNL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2011
Decision Date	12/27/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review