FDA 510(k) Application Details - K101365

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K101365
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD PO BOX 50416 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	KELLY O'MAINE ADAMS Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2010
Decision Date	10/05/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review