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FDA 510(k)

Oncomine ™ Dx Express Test

K-Number: K260827 · 2026-10-15

ApplicantLife Technologies Corporation
Decision Date2026-10-15
Product CodeSBY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Oncomine ™ Dx Express Test is the device name listed in this FDA 510(k) record. The listed applicant is Life Technologies Corporation. It received FDA 510(k) clearance on 2026-10-15 under 510(k) number K260827. The device is classified under product code SBY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oncomine ™ Dx Express Test?

Oncomine ™ Dx Express Test is a medical device that received FDA 510(k) clearance on 2026-10-15. The listed applicant is Life Technologies Corporation. The 510(k) number is K260827.

When did Oncomine ™ Dx Express Test receive FDA 510(k) clearance?

Oncomine ™ Dx Express Test received FDA 510(k) clearance on 2026-10-15, under 510(k) number K260827.

Who is the listed applicant for Oncomine ™ Dx Express Test?

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

What is the FDA product code for Oncomine ™ Dx Express Test?

The FDA product code for Oncomine ™ Dx Express Test is SBY.

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Other records listing Life Technologies Corporation as applicant

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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