Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K142689 |
Device Name |
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System |
Applicant |
Apex BioTechnology Corp. |
No. 7, Li-Hsin Road V, Hsinchu Science Park |
Hsinchu,
TW
30078
|
|
Applicant Contact |
Hsue-mei Lee |
Correspondent |
Apex BioTechnology Corp. |
No. 7, Li-Hsin Road V, Hsinchu Science Park |
Hsinchu,
TW
30078
|
|
Correspondent Contact |
Hsue-mei Lee |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/22/2014 |
Decision Date | 08/06/2015 |
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
|
|
|