FDA 510(k) Application Details - K011082

Device Classification Name	System, Test, Thyroid Autoantibody   More FDA Info for this Device
510(K) Number	K011082
Device Name	System, Test, Thyroid Autoantibody
Applicant	SCIMEDX CORP. 400 FORD RD. DENVILLE, NJ 07834 US Other 510(k) Applications for this Company
Contact	Gary Lehnus 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	04/10/2001
Decision Date	06/06/2001
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