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510(k) K140215

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2014
Date Received
January 28, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

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