Device Classification Name |
hemoglobin a1c test system
|
510(k) Number |
K140654 |
Device Name |
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls |
Applicant |
ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD, DEPT. 09V6 AP8 |
ABBOTT PARK,
IL
60064
|
|
Applicant Contact |
JUDITH R WALLACH |
Correspondent |
ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD, DEPT. 09V6 AP8 |
ABBOTT PARK,
IL
60064
|
|
Correspondent Contact |
JUDITH R WALLACH |
Regulation Number | 862.1373
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/14/2014 |
Decision Date | 05/22/2015 |
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
|
Recalls |
CDRH Recalls
|
|
|