Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K100437 |
Device Name |
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION |
Applicant |
BESTGEN BIOTECH CORP. |
7F, NO.186, JIAN 1ST RD., |
JHONGHE CITY, TAIPEI COUNTY,
TW
23511
|
|
Applicant Contact |
STEVEN SHEN |
Correspondent |
BESTGEN BIOTECH CORP. |
7F, NO.186, JIAN 1ST RD., |
JHONGHE CITY, TAIPEI COUNTY,
TW
23511
|
|
Correspondent Contact |
STEVEN SHEN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/17/2010 |
Decision Date | 01/12/2012 |
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
|
|
|