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FDA 510(k)

Tacrolimus Assay Kit

K-Number: K203833 · 2023-01-27

ApplicantShanghai Genext Medical Technology Co., Ltd.
Decision Date2023-01-27
Product CodeMLM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Tacrolimus Assay Kit is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Genext Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K203833. The device is classified under product code MLM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tacrolimus Assay Kit?

Tacrolimus Assay Kit is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Shanghai Genext Medical Technology Co., Ltd.. The 510(k) number is K203833.

When did Tacrolimus Assay Kit receive FDA 510(k) clearance?

Tacrolimus Assay Kit received FDA 510(k) clearance on 2023-01-27, under 510(k) number K203833.

Who is the listed applicant for Tacrolimus Assay Kit?

The FDA 510(k) record lists Shanghai Genext Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tacrolimus Assay Kit?

The FDA product code for Tacrolimus Assay Kit is MLM.

Related Devices (Code: MLM)

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.

K173857Elecsys TacrolimusRoche Diagnostics

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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