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FDA 510(k)

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers

K-Number: K201442 · 2020-07-31

ApplicantDiatron Group
Decision Date2020-07-31
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is a medical device manufactured by Diatron Group. It received FDA 510(k) clearance on 2020-07-31 under approval number K201442. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers?

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is a medical device that received FDA 510(k) clearance on 2020-07-31. It is manufactured by Diatron Group. The 510(k) number is K201442.

When was Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers approved by the FDA?

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers received FDA 510(k) clearance on 2020-07-31, under approval number K201442.

What company makes Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers?

Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is manufactured by Diatron Group.

What is the FDA product code for Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers?

The FDA product code for Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is LAF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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