Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K080960 |
Device Name |
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS |
Applicant |
ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP RD. |
ALAMEDA,
CA
94502
|
|
Applicant Contact |
TAMMY WHARTON |
Correspondent |
ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP RD. |
ALAMEDA,
CA
94502
|
|
Correspondent Contact |
TAMMY WHARTON |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/03/2008 |
Decision Date | 09/05/2008 |
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
|
|
|