FDA 510(k) Application Details - K063868

Device Classification Name	Enzyme Immunoassay, Tracrolimus   More FDA Info for this Device
510(K) Number	K063868
Device Name	Enzyme Immunoassay, Tracrolimus
Applicant	WATERS CORPORATION 163 CABOT STREET BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	FRAN WHITE 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	12/29/2006
Decision Date	05/25/2007
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