Cleared Traditional

K093243 - COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM (FDA 510(k) Clearance)

K093243 · Coagusense, Inc. · Hematology device

Apr 2010

Decision

174d

Days

Class 2

Risk

K093243 is an FDA 510(k) clearance for the COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).

Submitted by Coagusense, Inc. (Fremont, US). The FDA issued a Cleared decision on April 7, 2010, 174 days after receiving the submission on October 15, 2009.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number	K093243 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 15, 2009
Decision Date	April 07, 2010
Days to Decision	174 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF