Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K120866 |
Device Name |
DA01 BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
DELBIO INCORPORATION |
3F, NO. 252, SHANGYING ROAD |
GUISHAN INDUSTRIAL ZONE |
TAOYUAN COUNTY,
TW
33341
|
|
Applicant Contact |
NICKY PAN |
Correspondent |
DELBIO INCORPORATION |
3F, NO. 252, SHANGYING ROAD |
GUISHAN INDUSTRIAL ZONE |
TAOYUAN COUNTY,
TW
33341
|
|
Correspondent Contact |
NICKY PAN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/22/2012 |
Decision Date | 12/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|