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510(k) K153741

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test by Hangzhou Clongene Biotech Co., Ltd. — Product Code LDJ

K153741 is an FDA 510(k) premarket notification submitted by Hangzhou Clongene Biotech Co., Ltd. for the device "CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test". The FDA issued a decision of Substantially Equivalent on March 18, 2016. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Hangzhou Clongene Biotech Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2016
Date Received
December 28, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
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)
  • K161251 — CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests (August 30, 2016)

Other clearances for product code LDJ

  • K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapi (January 17, 2024)
  • K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test (January 10, 2024)
  • K223162 — Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test C (March 17, 2023)
  • K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY (October 11, 2019)
  • K152643 — EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Te (November 2, 2015)
  • K151203 — Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibr (June 5, 2015)
  • K141320 — LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Cali (May 28, 2015)
  • K142408 — FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep (September 25, 2014)
  • K140546 — HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST (June 6, 2014)
  • K132096 — RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECT (October 18, 2013)

FDA data resources