FDA 510(k) Application Details - K982954

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K982954
Device Name	Radioimmunoassay, Free Thyroxine
Applicant	BIOMERICA, INC. 1533 MONROVIA AVE. NEWPORT BEACH, CA 92663 US Other 510(k) Applications for this Company
Contact	JAY SINGH Other 510(k) Applications for this Contact
Regulation Number	862.1695   More FDA Info for this Regulation Number
Classification Product Code	CEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/1998
Decision Date	09/24/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review