Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K073030 |
Device Name |
AG-605 BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
ANDON HEALTH CO.,LTD |
YA AN RD NANKAI DISTRICT |
TIAJIN,
CN
300190
|
|
Applicant Contact |
MS. MONA |
Correspondent |
ANDON HEALTH CO.,LTD |
YA AN RD NANKAI DISTRICT |
TIAJIN,
CN
300190
|
|
Correspondent Contact |
MS. MONA |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/26/2007 |
Decision Date | 07/21/2008 |
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
|
|
|