FDA 510(k) Application Details - K020348

Device Classification Name	System, Test, Thyroid Autoantibody   More FDA Info for this Device
510(K) Number	K020348
Device Name	System, Test, Thyroid Autoantibody
Applicant	AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE DUNDEE, SCOTLAND DD2 1XA GB Other 510(k) Applications for this Company
Contact	EILEEN A MCCAFFERTY 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	02/04/2002
Decision Date	05/02/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review