FDA 510(k) Application Details - K060385

Device Classification Name	Enzyme Immunoassay, Tracrolimus   More FDA Info for this Device
510(K) Number	K060385
Device Name	Enzyme Immunoassay, Tracrolimus
Applicant	DADE BEHRING, INC. P.O. BOX 6101 NEWARK, DE 19714 US Other 510(k) Applications for this Company
Contact	YUK-TING LEWIS 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	02/14/2006
Decision Date	04/06/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review