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FDA 510(k)

Elecsys Tg II

K-Number: K221890 · 2023-09-30

ApplicantRoche Diagnostics
Decision Date2023-09-30
Product CodeMSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Elecsys Tg II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2023-09-30 under 510(k) number K221890. The device is classified under product code MSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys Tg II?

Elecsys Tg II is a medical device that received FDA 510(k) clearance on 2023-09-30. The listed applicant is Roche Diagnostics. The 510(k) number is K221890.

When did Elecsys Tg II receive FDA 510(k) clearance?

Elecsys Tg II received FDA 510(k) clearance on 2023-09-30, under 510(k) number K221890.

Who is the listed applicant for Elecsys Tg II?

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 Tg II?

The FDA product code for Elecsys Tg II is MSW.

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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.

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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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