FDA 510(k) Application Details - K120936

Device Classification Name	Calibrators, Drug Mixture   More FDA Info for this Device
510(K) Number	K120936
Device Name	Calibrators, Drug Mixture
Applicant	Microgenics Corporation 46360 FREMONT BLVD. FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	KAREN LEE Other 510(k) Applications for this Contact
Regulation Number	862.3200   More FDA Info for this Regulation Number
Classification Product Code	DKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2012
Decision Date	12/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review