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510(k) K182701

Wondfo T-Cup Multi-Drug Urine Test Cup by Guangzhou Wondfo Biotech Co., Ltd. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2018
Date Received
September 27, 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 Guangzhou Wondfo Biotech Co., Ltd.

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  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
  • K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test (June 27, 2016)
  • K152495 — Wondfo Propoxyphene Urine Test (November 23, 2015)
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