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510(k) K130213

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE by Lumiquick Diagnostics, Inc. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2013
Date Received
January 29, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

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