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FDA 510(k)

Alzevita

K-Number: K252670 · 2025-12-19

ApplicantTOPIA MEDTECH LIMITED
Decision Date2025-12-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Alzevita is the device name listed in this FDA 510(k) record. The listed applicant is TOPIA MEDTECH LIMITED. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K252670. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alzevita?

Alzevita is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is TOPIA MEDTECH LIMITED. The 510(k) number is K252670.

When did Alzevita receive FDA 510(k) clearance?

Alzevita received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252670.

Who is the listed applicant for Alzevita?

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

What is the FDA product code for Alzevita?

The FDA product code for Alzevita is QIH.

Related Devices (Code: QIH)

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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