FDA 510(k)

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

K-Number: K081769 · 2009-05-28

Decision Date2009-05-28

Product CodeJBQ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2009-05-28 under 510(k) number K081769. 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 WITH MODELS OPFH03, OPFHO5?

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 is a medical device that received FDA 510(k) clearance on 2009-05-28. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K081769.

When did INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 receive FDA 510(k) clearance?

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 received FDA 510(k) clearance on 2009-05-28, under 510(k) number K081769.

Who is the listed applicant for INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5?

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

What is the FDA product code for INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5?

The FDA product code for INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 is JBQ.

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Related Devices (Code: JBQ)

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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.