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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 the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2019-10-04 under 510(k) 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. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K192433.

When did LZI Methadone II Enzyme Immunoassay receive FDA 510(k) clearance?

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

Who is the listed applicant for LZI Methadone II Enzyme Immunoassay?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Lin-Zhi International, Inc. as applicant

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Related Devices (Code: DJR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182779ARK EDDP AssayArk Diagnostics, Inc.K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc.K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)W.H.P.M., Inc.

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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