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FDA 510(k)

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators

K-Number: K170416 · 2017-06-26

ApplicantLin-Zhi International, Inc.
Decision Date2017-06-26
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is a medical device manufactured by Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2017-06-26 under approval number K170416. 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 Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators?

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is a medical device that received FDA 510(k) clearance on 2017-06-26. It is manufactured by Lin-Zhi International, Inc.. The 510(k) number is K170416.

When was LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators approved by the FDA?

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators received FDA 510(k) clearance on 2017-06-26, under approval number K170416.

What company makes LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators?

LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is manufactured by Lin-Zhi International, Inc..

What is the FDA product code for LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators?

The FDA product code for LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators is 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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