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510(k) K121339

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2012
Date Received
May 3, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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