FDA 510(k) Application Details - K961650

Device Classification Name	Radioimmunoassay, Thyroid-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K961650
Device Name	Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant	NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY SAN JUAN CAPISTRANO, CA 92690-6130 US Other 510(k) Applications for this Company
Contact	DAVE D SMITH Other 510(k) Applications for this Contact
Regulation Number	862.1690   More FDA Info for this Regulation Number
Classification Product Code	JLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/1996
Decision Date	07/16/1996
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