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510(k) K230238

BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx by Shenzhen Bioeasy Biotechnology Co., Ltd. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2023
Date Received
January 30, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Shenzhen Bioeasy Biotechnology Co., Ltd.

  • 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)
  • K182530 — BIOEASY Multi-Drug Test Cup (November 9, 2018)

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