FDA 510(k) Application Details - K112029

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K112029
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	ELITECHGROUP 21720 23RD DR SE SUITE 150 BOTHELL, WA 98021 US Other 510(k) Applications for this Company
Contact	DEBRA K HUTSON 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	07/15/2011
Decision Date	08/30/2011
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