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510(k) K142800

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard by Co-Innovation Biotech Co., Ltd. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2014
Date Received
September 29, 2014
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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