FDA 510(k) Application Details - K965058

Device Classification Name	Radioimmunoassay, Total Triiodothyronine   More FDA Info for this Device
510(K) Number	K965058
Device Name	Radioimmunoassay, Total Triiodothyronine
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	862.1710   More FDA Info for this Regulation Number
Classification Product Code	CDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/1996
Decision Date	03/11/1997
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