Device Classification Name |
Test, Time, Prothrombin
|
510(k) Number |
K020679 |
Device Name |
INRATIO |
Applicant |
HEMOSENSE, INC. |
600 VALLEY WAY |
MILPITAS,
CA
95035
|
|
Applicant Contact |
Judith Blunt |
Correspondent |
HEMOSENSE, INC. |
600 VALLEY WAY |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
Judith Blunt |
Regulation Number | 864.7750
|
Classification Product Code |
|
Date Received | 03/04/2002 |
Decision Date | 05/06/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|