FDA 510(k) Application Details - K092113

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K092113
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	DIAGNOSTICA STAGO, INC. 5 CENTURY DR. PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	UMBERTO V PARROTTA Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2009
Decision Date	11/13/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review