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510(k) K242802

Device
CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
Applicant
Hangzhou Clongene Biotech Co., Ltd.
510(k) number
K242802
Product code
NGL
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-08
Date received
2024-09-17
Regulation
862.3650
Classification name
Test, Opiates, Over The Counter
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Frank Zheng
Address
#1 Yichuang Rd., Yuhang District Hangzhou CN 311121 311121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NGL#

510(k), Device, Applicant table
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K241869BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart ReaderVivachek Biotech (Hangzhou) Co., Ltd.2024-10-04
K241969Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test PanelQingdao Hightop Biotech Co., Ltd.2024-08-14
K241741SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test PanelGuangzhou Wondfo Biotech Co., Ltd.2024-07-16
K241100Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test DipcardCo-Innovation Biotech Co., Ltd.2024-05-22
K240949Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)Healgen Scientific,, LLC2024-05-13
K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLC2024-04-12
K240654SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.2024-04-10
K240295InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)Instanosis, Inc.2024-03-28
K234006AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl TestAllsource Screening Solutions2024-03-21