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FDA 510(k)

LZI Fentanyl Enzyme Immunoassay

K-Number: K181159 · 2018-12-03

ApplicantLin-Zhi International, Inc.
Decision Date2018-12-03
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LZI Fentanyl 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 2018-12-03 under 510(k) number K181159. 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 Enzyme Immunoassay?

LZI Fentanyl Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2018-12-03. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K181159.

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

LZI Fentanyl Enzyme Immunoassay received FDA 510(k) clearance on 2018-12-03, under 510(k) number K181159.

Who is the listed applicant for LZI Fentanyl 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 Enzyme Immunoassay?

The FDA product code for LZI Fentanyl 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 ImmunoassayK251634LZI Fentanyl III Enzyme ImmunoassayK202007LZI Oxycodone III Enzyme ImmunoassayK201938LZI Fentanyl II Enzyme ImmunoassayK201223LZI Tramadol Enzyme ImmunoassayK192299LZI Cotinine 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,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

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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