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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 a medical device manufactured by Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2018-12-03 under approval 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. It is manufactured by Lin-Zhi International, Inc.. The 510(k) number is K181159.

When was LZI Fentanyl Enzyme Immunoassay approved by the FDA?

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

What company makes LZI Fentanyl Enzyme Immunoassay?

LZI Fentanyl Enzyme Immunoassay is manufactured by Lin-Zhi International, Inc..

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

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

Other Devices by Lin-Zhi International, Inc.

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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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