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510(k) K063868

MASSTRAK IMMUNOSUPPRESSANTS KIT by Waters Corporation — Product Code MLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2007
Date Received
December 29, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Tracrolimus
Device Class
Class II
Regulation Number
862.1678
Review Panel
TX
Submission Type

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