INNOVANCE Antithrombin
K-Number: K242952 · 2025-03-28
Decision Date2025-03-28
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
INNOVANCE Antithrombin is a medical device manufactured by Siemens Healthcare Diagnostic Products GmbH. It received FDA 510(k) clearance on 2025-03-28 under approval 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. It is manufactured by Siemens Healthcare Diagnostic Products GmbH. The 510(k) number is K242952.
When was INNOVANCE Antithrombin approved by the FDA?
INNOVANCE Antithrombin received FDA 510(k) clearance on 2025-03-28, under approval number K242952.
What company makes INNOVANCE Antithrombin?
INNOVANCE Antithrombin is manufactured by Siemens Healthcare Diagnostic Products GmbH.
What is the FDA product code for INNOVANCE Antithrombin?
The FDA product code for INNOVANCE Antithrombin is JBQ.
Other Devices by Siemens Healthcare Diagnostic Products GmbH
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.