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510(k) K182530

BIOEASY Multi-Drug Test Cup by Shenzhen Bioeasy Biotechnology Co., Ltd. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2018
Date Received
September 14, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Amphetamine, Over The Counter
Device Class
Class II
Regulation Number
862.3100
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)
  • K192301 — BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip (September 20, 2019)

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