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510(k) K161251

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests by Hangzhou Clongene Biotech Co., Ltd. — Product Code DKZ

K161251 is an FDA 510(k) premarket notification submitted by Hangzhou Clongene Biotech Co., Ltd. for the device "CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests". The FDA issued a decision of Substantially Equivalent on August 30, 2016. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Hangzhou Clongene Biotech Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2016
Date Received
May 3, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Hangzhou Clongene Biotech Co., Ltd.

  • K253318 — Clungene RSV Antigen Rapid Test (January 30, 2026)
  • K252118 — CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (August 27, 2025)
  • K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (November 8, 2024)
  • K193132 — CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test St (December 11, 2019)
  • 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)
  • K153741 — CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test (March 18, 2016)

Other clearances for product code DKZ

  • K240670 — DRI Ecstasy Plus Assay (October 30, 2024)
  • K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest (December 13, 2023)
  • K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (May 19, 2023)
  • K200363 — Quidel Triage® TOX Drug Screen, 94600 (March 11, 2020)
  • K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (October 3, 2019)
  • K182719 — Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (June 19, 2019)
  • K182738 — Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Mul (March 27, 2019)
  • K180879 — BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi- (December 14, 2018)
  • K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z (October 18, 2018)
  • K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT (February 23, 2018)

FDA data resources