Device Classification Name |
assay, glycosylated hemoglobin
|
510(k) Number |
K983253 |
Device Name |
PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT |
Applicant |
MEDISENSE, INC. |
4-A CROSBY DR. |
BEDFORD,
MA
01730 -1402
|
|
Applicant Contact |
DENISE HALEY |
Correspondent |
MEDISENSE, INC. |
4-A CROSBY DR. |
BEDFORD,
MA
01730 -1402
|
|
Correspondent Contact |
DENISE HALEY |
Regulation Number | 864.7470
|
Classification Product Code |
|
Date Received | 09/16/1998 |
Decision Date | 11/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|