Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K062892 |
Device Name |
EUKARE |
Applicant |
EUMED BIOTECHNOLOGY CO., LTD. |
NO. 58, FU-CHIUN ST. |
HSIN CHU CITY,
TW
300
|
|
Applicant Contact |
Ke-Min Jen |
Correspondent |
EUMED BIOTECHNOLOGY CO., LTD. |
NO. 58, FU-CHIUN ST. |
HSIN CHU CITY,
TW
300
|
|
Correspondent Contact |
Ke-Min Jen |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/26/2006 |
Decision Date | 01/22/2007 |
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
|
Recalls |
CDRH Recalls
|
|
|