Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K122110 |
Device Name |
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
ACON LABORATORIES, INC. |
10125 MESA RIM ROAD |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
QIYI XIE |
Correspondent |
ACON LABORATORIES, INC. |
10125 MESA RIM ROAD |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
QIYI XIE |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/17/2012 |
Decision Date | 11/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|