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510(k) K192301

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2019
Date Received
August 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Cannabinoid, Over The Counter
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

Other clearances by Shenzhen Bioeasy Biotechnology Co., Ltd.

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  • K193480 — BIOEASY Multi-Drug Test Cup (January 31, 2020)
  • K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY (October 11, 2019)
  • K182530 — BIOEASY Multi-Drug Test Cup (November 9, 2018)

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  • K191924 — SAFECARE® THC Urine Strip Test (August 16, 2019)