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FDA 510(k)

Atellica IM CA 19-9 II

K-Number: K253528 · 2026-08-10

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2026-08-10
Product CodeNIG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Atellica IM CA 19-9 II is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K253528. The device is classified under product code NIG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atellica IM CA 19-9 II?

Atellica IM CA 19-9 II is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K253528.

When did Atellica IM CA 19-9 II receive FDA 510(k) clearance?

Atellica IM CA 19-9 II received FDA 510(k) clearance on 2026-08-10, under 510(k) number K253528.

Who is the listed applicant for Atellica IM CA 19-9 II?

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

What is the FDA product code for Atellica IM CA 19-9 II?

The FDA product code for Atellica IM CA 19-9 II is NIG.

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Related Devices (Code: NIG)

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K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackOrtho Clinical DiagnosticsK200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc.K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.

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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