Device Classification Name |
Glucose Dehydrogenase, Glucose
|
510(k) Number |
K121433 |
Device Name |
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS |
Applicant |
HMD BIOMEDICAL, INC. |
#181 MINSHENG STREET |
XINPU TOWNSHIP, HSINCHU COUNTY,
TW
305
|
|
Applicant Contact |
JESSICA TUNG |
Correspondent |
HMD BIOMEDICAL, INC. |
#181 MINSHENG STREET |
XINPU TOWNSHIP, HSINCHU COUNTY,
TW
305
|
|
Correspondent Contact |
JESSICA TUNG |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/14/2012 |
Decision Date | 02/14/2013 |
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
|
|
|