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510(k) K152590

ACCU NEWS Drug Screening Test Card/Urine Cup by Coretests, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2016
Date Received
September 10, 2015
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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