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FDA 510(k)

LZI Methadone II Enzyme Immunoassay

K-Number: K192433 · 2019-10-04

ApplicantLin-Zhi International, Inc.
Decision Date2019-10-04
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LZI Methadone II Enzyme Immunoassay is a medical device manufactured by Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2019-10-04 under approval number K192433. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LZI Methadone II Enzyme Immunoassay?

LZI Methadone II Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2019-10-04. It is manufactured by Lin-Zhi International, Inc.. The 510(k) number is K192433.

When was LZI Methadone II Enzyme Immunoassay approved by the FDA?

LZI Methadone II Enzyme Immunoassay received FDA 510(k) clearance on 2019-10-04, under approval number K192433.

What company makes LZI Methadone II Enzyme Immunoassay?

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

What is the FDA product code for LZI Methadone II Enzyme Immunoassay?

The FDA product code for LZI Methadone II Enzyme Immunoassay is DJR.

Other Devices by Lin-Zhi International, Inc.

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Related Devices (Code: DJR)

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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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