FDA 510(k) Application Details - K003291

Device Classification Name	System, Test, Thyroid Autoantibody   More FDA Info for this Device
510(K) Number	K003291
Device Name	System, Test, Thyroid Autoantibody
Applicant	BAYER DIAGNOSTICS CORP. 63 NORTH ST. MEDFIELD, MA 02052 US Other 510(k) Applications for this Company
Contact	William J Pignato Other 510(k) Applications for this Contact
Regulation Number	866.5870   More FDA Info for this Regulation Number
Classification Product Code	JZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2000
Decision Date	12/05/2000
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