FDA 510(k) Application Details - K964635

Device Classification Name	Radioimmunoassay, Calcitonin   More FDA Info for this Device
510(K) Number	K964635
Device Name	Radioimmunoassay, Calcitonin
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	862.1140   More FDA Info for this Regulation Number
Classification Product Code	JKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/1996
Decision Date	05/21/1997
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