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 Number | 864.7750
|
Classification Product Code |
|
Date Received | 09/01/2021 |
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
|
|
|