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FDA 510(k)

INNOVANCE Antithrombin

K-Number: K242952 · 2025-03-28

ApplicantSiemens Healthcare Diagnostic Products GmbH
Decision Date2025-03-28
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INNOVANCE Antithrombin is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. It received FDA 510(k) clearance on 2025-03-28 under 510(k) number K242952. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVANCE Antithrombin?

INNOVANCE Antithrombin is a medical device that received FDA 510(k) clearance on 2025-03-28. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. The 510(k) number is K242952.

When did INNOVANCE Antithrombin receive FDA 510(k) clearance?

INNOVANCE Antithrombin received FDA 510(k) clearance on 2025-03-28, under 510(k) number K242952.

Who is the listed applicant for INNOVANCE Antithrombin?

The FDA 510(k) record lists Siemens Healthcare Diagnostic Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVANCE Antithrombin?

The FDA product code for INNOVANCE Antithrombin is JBQ.

Other records listing Siemens Healthcare Diagnostic Products GmbH 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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