FDA 510(k) Application Details - K012208

Device Classification Name	Thyroglobulin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K012208
Device Name	Thyroglobulin, Antigen, Antiserum, Control
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	DENISE THOMPSON Other 510(k) Applications for this Contact
Regulation Number	866.5870   More FDA Info for this Regulation Number
Classification Product Code	DDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2001
Decision Date	09/07/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review