Device Classification Name |
Assay, Glycosylated Hemoglobin
|
510(k) Number |
K991483 |
Device Name |
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN |
Applicant |
ABBOTT LABORATORIES |
200 ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064
|
|
Applicant Contact |
KATHERINE M WORTLEY |
Correspondent |
ABBOTT LABORATORIES |
200 ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064
|
|
Correspondent Contact |
KATHERINE M WORTLEY |
Regulation Number | 864.7470
|
Classification Product Code |
|
Date Received | 04/28/1999 |
Decision Date | 11/01/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|