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510(k) K150168

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) by Siemens Healthcare Diagnostics — Product Code MLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2015
Date Received
January 26, 2015
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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