Device Classification Name |
Hemoglobin A1c Test System
|
510(k) Number |
K151321 |
FOIA Releasable 510(k) |
K151321
|
Device Name |
D-100 HbA1c, D-100 HbA1c Calibrator Pack |
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 |
|
Subsequent Product Codes |
|
Date Received | 05/18/2015 |
Decision Date | 12/09/2015 |
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
|
|
|