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510(k) K080085

MAS TOX CONTROL by Thermo Fisher Scientific — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2008
Date Received
January 11, 2008
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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