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510(k) K123080

CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS by Chemtron Biotech, Inc. — Product Code JXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2012
Date Received
October 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
Review Panel
TX
Submission Type

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