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FDA 510(k)

LZI Fentanyl III Enzyme Immunoassay

K-Number: K251634 · 2025-06-18

ApplicantLin-Zhi International, Inc.
Decision Date2025-06-18
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LZI Fentanyl III Enzyme Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K251634. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LZI Fentanyl III Enzyme Immunoassay?

LZI Fentanyl III Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K251634.

When did LZI Fentanyl III Enzyme Immunoassay receive FDA 510(k) clearance?

LZI Fentanyl III Enzyme Immunoassay received FDA 510(k) clearance on 2025-06-18, under 510(k) number K251634.

Who is the listed applicant for LZI Fentanyl III Enzyme Immunoassay?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LZI Fentanyl III Enzyme Immunoassay?

The FDA product code for LZI Fentanyl III Enzyme Immunoassay is DJG.

Other records listing Lin-Zhi International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253082LZI Buprenorphine II Enzyme ImmunoassayK202007LZI Oxycodone III Enzyme ImmunoassayK201938LZI Fentanyl II Enzyme ImmunoassayK201223LZI Tramadol Enzyme ImmunoassayK192299LZI Cotinine II Enzyme ImmunoassayK192433LZI Methadone II Enzyme Immunoassay

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Related Devices (Code: DJG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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