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510(k) K193480

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2020
Date Received
December 16, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Opiates, Over The Counter
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Shenzhen Bioeasy Biotechnology Co., Ltd.

  • K230238 — BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test C (March 31, 2023)
  • 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)
  • K182530 — BIOEASY Multi-Drug Test Cup (November 9, 2018)

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