FDA 510(k) Application Details - K151552

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K151552
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	ELITechGroup ZONE INDUSTRIELLE Sees 61500 FR Other 510(k) Applications for this Company
Contact	Valerie Gourdon 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	06/09/2015
Decision Date	07/08/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review