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FDA 510(k)

Eonis™ SMA kit

K-Number: K262893 · 2026-09-30

ApplicantRevvity, Inc.
Decision Date2026-09-30
Product CodeQUE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Eonis™ SMA kit is the device name listed in this FDA 510(k) record. The listed applicant is Revvity, Inc.. It received FDA 510(k) clearance on 2026-09-30 under 510(k) number K262893. The device is classified under product code QUE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eonis™ SMA kit?

Eonis™ SMA kit is a medical device that received FDA 510(k) clearance on 2026-09-30. The listed applicant is Revvity, Inc.. The 510(k) number is K262893.

When did Eonis™ SMA kit receive FDA 510(k) clearance?

Eonis™ SMA kit received FDA 510(k) clearance on 2026-09-30, under 510(k) number K262893.

Who is the listed applicant for Eonis™ SMA kit?

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

What is the FDA product code for Eonis™ SMA kit?

The FDA product code for Eonis™ SMA kit is QUE.

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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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