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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 the device name listed in this FDA 510(k) record. The listed applicant is Coagusense, Inc.. It received FDA 510(k) clearance on 2019-02-21 under 510(k) 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. The listed applicant is Coagusense, Inc.. The 510(k) number is K183255.

When did Coag-Sense Prothrombin Time (PT) / INR Monitoring Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Coag-Sense Prothrombin Time (PT) / INR Monitoring Device?

The FDA 510(k) record lists Coagusense, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Coagusense, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: GJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR 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.

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