FDA 510(k) Application Details - K060585

Device Classification Name	Radioimmunoassay, Acth   More FDA Info for this Device
510(K) Number	K060585
Device Name	Radioimmunoassay, Acth
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	RANDY JOHNSON Other 510(k) Applications for this Contact
Regulation Number	862.1025   More FDA Info for this Regulation Number
Classification Product Code	CKG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2006
Decision Date	05/03/2006
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