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510(k) K102203

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2011
Date Received
August 4, 2010
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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