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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K212779
Device Name Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
Applicant
Coagusense, Inc.
48377 Fremont Blvd. Suite 113
Fremont,  CA  94538
Applicant Contact Michael Acosta
Correspondent
Coagusense, Inc.
48377 Fremont Blvd. Suite 113
Fremont,  CA  94538
Correspondent Contact Robin Bush
Regulation Number864.7750
Classification Product Code
GJS  
Date Received09/01/2021
Decision Date 10/05/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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