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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 a medical device manufactured by Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2025-06-18 under approval 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. It is manufactured by Lin-Zhi International, Inc.. The 510(k) number is K251634.

When was LZI Fentanyl III Enzyme Immunoassay approved by the FDA?

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

What company makes LZI Fentanyl III Enzyme Immunoassay?

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

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 Devices by Lin-Zhi International, Inc.

K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators K181159LZI Fentanyl Enzyme Immunoassay DEN170010LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay K192299LZI Cotinine II Enzyme Immunoassay K192433LZI Methadone II Enzyme Immunoassay K202007LZI Oxycodone III Enzyme Immunoassay

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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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