FDA 510(k) Application Details - K132828

Device Classification Name	Radioimmunoassay, Calcitonin   More FDA Info for this Device
510(K) Number	K132828
Device Name	Radioimmunoassay, Calcitonin
Applicant	Roche Diagnostics 9115 HAGUE ROAD INDIANAPOLIS, IN 46250-0416 US Other 510(k) Applications for this Company
Contact	KELLI TURNER 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	09/09/2013
Decision Date	12/04/2013
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