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510(k) K060788

TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 by Biosite Incorporated — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2006
Date Received
March 23, 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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