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510(k) K070820

ARCHITECT TACROLIMUS: MODEL 1L77 by Fujirebio Diagnostics,Inc. — Product Code MLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2007
Date Received
March 26, 2007
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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