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FDA 510(k)

LZI Buprenorphine II Enzyme Immunoassay

K-Number: K253082 · 2026-01-16

ApplicantLin-Zhi International, Inc.
Decision Date2026-01-16
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LZI Buprenorphine II Enzyme Immunoassay is a medical device manufactured by Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2026-01-16 under approval number K253082. 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 Buprenorphine II Enzyme Immunoassay?

LZI Buprenorphine II Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2026-01-16. It is manufactured by Lin-Zhi International, Inc.. The 510(k) number is K253082.

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

LZI Buprenorphine II Enzyme Immunoassay received FDA 510(k) clearance on 2026-01-16, under approval number K253082.

What company makes LZI Buprenorphine II Enzyme Immunoassay?

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

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

The FDA product code for LZI Buprenorphine II Enzyme Immunoassay is DJG.

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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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