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510(k) K050037

TRIAGE TOX DRUG SCREEN CONTROLS by Biosite Incorporated — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2005
Date Received
January 7, 2005
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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