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FDA 510(k)

Elecsys Tacrolimus

K-Number: K173857 · 2018-11-06

ApplicantRoche Diagnostics
Decision Date2018-11-06
Product CodeMLM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys Tacrolimus is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2018-11-06 under 510(k) number K173857. 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 Elecsys Tacrolimus?

Elecsys Tacrolimus is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is Roche Diagnostics. The 510(k) number is K173857.

When did Elecsys Tacrolimus receive FDA 510(k) clearance?

Elecsys Tacrolimus received FDA 510(k) clearance on 2018-11-06, under 510(k) number K173857.

Who is the listed applicant for Elecsys Tacrolimus?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elecsys Tacrolimus?

The FDA product code for Elecsys Tacrolimus is MLM.

Other records listing Roche Diagnostics as applicant

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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.

K203833Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd.

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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