FDA 510(k) Application Details - K981243

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K981243
Device Name	Radioimmunoassay, Free Thyroxine
Applicant	BIOSTRIDE DIAGNOSTICS, INC. 1206 SESAME DR. SUNNYVALE, CA 94087 US Other 510(k) Applications for this Company
Contact	JANIS FREESTONE 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	04/06/1998
Decision Date	06/29/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review