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510(k) K122809

Advin Multi-Drug Screen Test Cassette, Dip Card and Cup by Advin Biotech — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2013
Date Received
September 13, 2012
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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