Device Classification Name |
glucose dehydrogenase, glucose
|
510(k) Number |
K000582 |
Device Name |
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 |
Applicant |
ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP DR. |
ALAMEDA,
CA
94502 -7000
|
|
Applicant Contact |
EVE CONNER |
Correspondent |
ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP DR. |
ALAMEDA,
CA
94502 -7000
|
|
Correspondent Contact |
EVE CONNER |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/22/2000 |
Decision Date | 12/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|