Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K120649 |
Device Name |
AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
APEX BIO TECHNOLOGY CORP |
NO. 7, LI-HSIN ROAD V |
HSINCHU SCIENCE PARK |
HSINCHU,
TW
30078
|
|
Applicant Contact |
LISA LIU |
Correspondent |
APEX BIO TECHNOLOGY CORP |
NO. 7, LI-HSIN ROAD V |
HSINCHU SCIENCE PARK |
HSINCHU,
TW
30078
|
|
Correspondent Contact |
LISA LIU |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/02/2012 |
Decision Date | 07/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|