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510(k) K062191

DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 by Dade Behring, Inc. — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2006
Date Received
July 31, 2006
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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