FDA 510(k) Application Details - K102814

Device Classification Name	Radioimmunoassay, Testosterones And Dihydrotestosterone   More FDA Info for this Device
510(K) Number	K102814
Device Name	Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant	Roche Diagnostics 9115 HAGUE ROAD INDIANAPOLIS, IN 46250-0416 US Other 510(k) Applications for this Company
Contact	KELLY FRENCH Other 510(k) Applications for this Contact
Regulation Number	862.1680   More FDA Info for this Regulation Number
Classification Product Code	CDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2010
Decision Date	01/20/2011
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