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FDA 510(k)

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

K-Number: K183255 · 2019-02-21

ApplicantCoagusense, Inc.
Decision Date2019-02-21
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Coag-Sense Prothrombin Time (PT) / INR Monitoring Device is a medical device manufactured by Coagusense, Inc.. It received FDA 510(k) clearance on 2019-02-21 under approval number K183255. 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 Time (PT) / INR Monitoring Device?

Coag-Sense Prothrombin Time (PT) / INR Monitoring Device is a medical device that received FDA 510(k) clearance on 2019-02-21. It is manufactured by Coagusense, Inc.. The 510(k) number is K183255.

When was Coag-Sense Prothrombin Time (PT) / INR Monitoring Device approved by the FDA?

Coag-Sense Prothrombin Time (PT) / INR Monitoring Device received FDA 510(k) clearance on 2019-02-21, under approval number K183255.

What company makes Coag-Sense Prothrombin Time (PT) / INR Monitoring Device?

Coag-Sense Prothrombin Time (PT) / INR Monitoring Device is manufactured by Coagusense, Inc..

What is the FDA product code for Coag-Sense Prothrombin Time (PT) / INR Monitoring Device?

The FDA product code for Coag-Sense Prothrombin Time (PT) / INR Monitoring Device is GJS.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41644679 Scaling medical device regulatory science using large language models. NPJ digital medicine (2026)

Other Devices by Coagusense, Inc.

K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

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 K180780microINR SystemIline Microsystems, S.L. K201185microINR SystemIline Microsystems, S.L.

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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