FDA 510(k) Application Details - K123343

Device Classification Name	Enzyme Immunoassay, Tracrolimus   More FDA Info for this Device
510(K) Number	K123343
Device Name	Enzyme Immunoassay, Tracrolimus
Applicant	MICROGENICS CORP. 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	862.1678   More FDA Info for this Regulation Number
Classification Product Code	MLM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2012
Decision Date	07/11/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review