Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K103116 |
Device Name |
AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
BESTGEN BIOTECH CORP. |
7F, NO 186, JIAN-YI ROAD |
JUNG-HE, TAIPEI COUNTY,
TW
235
|
|
Applicant Contact |
STEVEN SHEN |
Correspondent |
BESTGEN BIOTECH CORP. |
7F, NO 186, JIAN-YI ROAD |
JUNG-HE, TAIPEI COUNTY,
TW
235
|
|
Correspondent Contact |
STEVEN SHEN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/21/2010 |
Decision Date | 03/13/2012 |
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
|
|
|