Coagusense Self-Test Prothrombin Time/Inr Monitoring System

FDA 510(k) K093243 · Coagusense, Inc.

Substantially Equivalent

510(k) numberK093243

Submission

Device name
Coagusense Self-Test Prothrombin Time/Inr Monitoring System
Applicant
Coagusense, Inc.
Fremont, CA, US
Received
October 15, 2009
Decision date
April 7, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

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K211485STA- NeoPTimalGJS · Traditional Diagnostica Stago S.A.S12/23/2022SE
K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingGJS · Special Coagusense, Inc.10/05/2022SE
K213426HemosIL ReadiPlasTinGJS · Traditional Instrumentation Laboratory CO08/16/2022SE
K201185microINR SystemGJS · Traditional Iline Microsystems, S.L.12/18/2020SE

More from Iline Microsystems, S.L.

510(k)DeviceDecision
K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingGJS · Special 10/05/2022SE
K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceGJS · Traditional 02/21/2019SE

Questions and answers

When was Coagusense Self-Test Prothrombin Time/Inr Monitoring System cleared by the FDA?

Coagusense Self-Test Prothrombin Time/Inr Monitoring System (K093243) received a 510(k) decision of Substantially Equivalent on April 7, 2010, 174 days after the submission was received.

What is the product code of K093243?

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