FDA 510(k)

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

K-Number: K212779 · 2022-10-05

Decision Date2022-10-05

Product CodeGJS

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing is a medical device manufactured by Coagusense, Inc.. It received FDA 510(k) clearance on 2022-10-05 under approval number K212779. 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 Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing?

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing is a medical device that received FDA 510(k) clearance on 2022-10-05. It is manufactured by Coagusense, Inc.. The 510(k) number is K212779.

When was Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing approved by the FDA?

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing received FDA 510(k) clearance on 2022-10-05, under approval number K212779.

What company makes Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing?

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing is manufactured by Coagusense, Inc..

What is the FDA product code for Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing?

The FDA product code for Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing is GJS.

Related Clinical Trials

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Related PubMed Literature

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Other Devices by Coagusense, Inc.

K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring Device

Related Devices (Code: GJS)

K151964Xprecia Stride Coagulation System, Xprecia System PT ControlsSiemens Healthcare Diagnostics K170960CoaguChek Vantus SystemRoche Diagnostics K180684CoaguChek XS Plus SystemRoche Diagnostics K180693CoaguChek XS Pro SystemRoche Diagnostics K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. K180780microINR SystemIline Microsystems, S.L.

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.