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510(k) K131110

ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD by Co-Innovation Biotech Co., Ltd. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2014
Date Received
April 19, 2013
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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