FDA 510(k) Application Details - K093421

Device Classification Name	Radioimmunoassay, Testosterones And Dihydrotestosterone   More FDA Info for this Device
510(K) Number	K093421
Device Name	Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50410 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	Sarah Baumann 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	11/03/2009
Decision Date	04/23/2010
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