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510(k) K121143

LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) by Bio-Rad Laboratories — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2012
Date Received
April 16, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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