Home / 510(k) Clearances / K192515

510(k) K192515

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 by Shenzhen Bioeasy Biotechnology Co., Ltd. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2019
Date Received
September 13, 2019
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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