Device Classification Name |
Hemoglobin A1c Test System
|
510(k) Number |
K161687 |
Device Name |
D-10 Hemoglobin A1c Program |
Applicant |
BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR. |
HERCULES,
CA
94547
|
|
Applicant Contact |
JACKIE BUCKLEY |
Correspondent |
BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR. |
HERCULES,
CA
94547
|
|
Correspondent Contact |
JACKIE BUCKLEY |
Regulation Number | 862.1373
|
Classification Product Code |
|
Date Received | 06/17/2016 |
Decision Date | 10/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|