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510(k) K152643

EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana by Nantong Egens Biotech Co., Ltd. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2015
Date Received
September 15, 2015
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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