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

FDA 510(k) K212779 · Coagusense, Inc.

Substantially Equivalent

510(k) numberK212779

Submission

Device name
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
Applicant
Coagusense, Inc.
Fremont, CA, US
Received
September 1, 2021
Decision date
October 5, 2022
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GJS – Test, Time, Prothrombin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7750
Specialty
Hematology

Other 510(k)s with product code GJS

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K253188CoaguChek XS Plus SystemGJS · Special Roche Diagnostics10/24/2025SE
K251564microINR SystemGJS · Traditional Iline Microsystems, S.L.07/21/2025SE
K243543microINR SystemGJS · Traditional Iline Microsystems, S.L.02/27/2025SE
K230802Xprecia Prime Coagulation SystemGJS · Dual Track Universal Biosensors Pty, Ltd.03/15/2024SE
K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional Abbott Laboratories07/14/2023SE
K231711microINR SystemGJS · Special Iline Microsystems, S.L.07/11/2023SE
K211485STA- NeoPTimalGJS · Traditional Diagnostica Stago S.A.S12/23/2022SE
K213426HemosIL ReadiPlasTinGJS · Traditional Instrumentation Laboratory CO08/16/2022SE
K201185microINR SystemGJS · Traditional Iline Microsystems, S.L.12/18/2020SE
K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceGJS · Traditional Coagusense, Inc.02/21/2019SE

More from Coagusense, Inc.

510(k)DeviceDecision
K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceGJS · Traditional 02/21/2019SE
K093243Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemGJS · Traditional 04/07/2010SE

Questions and answers

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

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (K212779) received a 510(k) decision of Substantially Equivalent on October 5, 2022, 399 days after the submission was received.

What is the product code of K212779?

The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.