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510(k) K242802

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette by Hangzhou Clongene Biotech Co., Ltd. — Product Code NGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2024
Date Received
September 17, 2024
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

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  • K190412 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (March 21, 2019)
  • K181790 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (July 26, 2018)
  • K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (February 28, 2018)
  • K161251 — CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests (August 30, 2016)
  • K153741 — CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test (March 18, 2016)

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