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510(k) K251634

Device
LZI Fentanyl III Enzyme Immunoassay
Applicant
Lin-Zhi International, Inc.
510(k) number
K251634
Product code
DJG
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-18
Date received
2025-05-29
Regulation
862.3650
Classification name
Enzyme Immunoassay, Opiates
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Chris Wang
Address
2945 Oakmead Village Ct. Santa Clara CA US 95051 95051

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DJG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.2026-01-29
K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited2026-01-23
K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.2026-01-16
K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation2025-09-11
K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLC2025-08-15
K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd.2024-06-14
K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardGuangzhou Decheng Biotechnology Co., Ltd.2024-05-10
K231904Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardCo-Innovation Biotech Co., Ltd.2024-03-08
K232228Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip CardShanghai Accurature Diagnostics Co., Ltd.2024-02-23
K232597LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)Hangzhou Laihe Biotech Co., Ltd.2024-01-09
K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card TestChemtron Biotech, Inc.2023-12-20
K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupGuangzhou Decheng Biotechnology Co., Ltd.2023-12-13
K231752ARK Hydrocodone AssayArk Diagnostics, Inc.2023-11-09
K221550Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited2023-10-05
K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited2023-10-05