FDA 510(k) Application Details - K101863

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K101863
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	SEBIA 1705 CORPORATE DRIVE SUITE 400 NORCROSS, GA 30093 US Other 510(k) Applications for this Company
Contact	KAREN ANDERSON Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2010
Decision Date	11/07/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review