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FDA 510(k)

Xprecia Stride Coagulation System, Xprecia System PT Controls

K-Number: K151964 · 2016-09-30

ApplicantSiemens Healthcare Diagnostics
Decision Date2016-09-30
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Xprecia Stride Coagulation System, Xprecia System PT Controls is a medical device manufactured by Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2016-09-30 under approval number K151964. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xprecia Stride Coagulation System, Xprecia System PT Controls?

Xprecia Stride Coagulation System, Xprecia System PT Controls is a medical device that received FDA 510(k) clearance on 2016-09-30. It is manufactured by Siemens Healthcare Diagnostics. The 510(k) number is K151964.

When was Xprecia Stride Coagulation System, Xprecia System PT Controls approved by the FDA?

Xprecia Stride Coagulation System, Xprecia System PT Controls received FDA 510(k) clearance on 2016-09-30, under approval number K151964.

What company makes Xprecia Stride Coagulation System, Xprecia System PT Controls?

Xprecia Stride Coagulation System, Xprecia System PT Controls is manufactured by Siemens Healthcare Diagnostics.

What is the FDA product code for Xprecia Stride Coagulation System, Xprecia System PT Controls?

The FDA product code for Xprecia Stride Coagulation System, Xprecia System PT Controls is GJS.

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Related Devices (Code: GJS)

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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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