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510(k) K111322

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2011
Date Received
May 11, 2011
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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