Device Classification Name |
assay, glycosylated hemoglobin
|
510(k) Number |
K936285 |
Device Name |
ABBOTT VISION GLYCATED HB, MODIFICATION |
Applicant |
ABBOTT LABORATORIES |
ABBOTT PARK,
IL
60064
|
|
Applicant Contact |
Irene Powers |
Correspondent |
ABBOTT LABORATORIES |
ABBOTT PARK,
IL
60064
|
|
Correspondent Contact |
Irene Powers |
Regulation Number | 864.7470
|
Classification Product Code |
|
Date Received | 12/30/1993 |
Decision Date | 06/09/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|