FDA 510(k) Application Details - K962451

Device Classification Name	Immunochemical, Thyroglobulin Autoantibody   More FDA Info for this Device
510(K) Number	K962451
Device Name	Immunochemical, Thyroglobulin Autoantibody
Applicant	HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. GARDEN GROVE, CA 92841 US Other 510(k) Applications for this Company
Contact	MEHDI ALEM 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	06/18/1996
Decision Date	11/25/1996
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