Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K043197 |
Device Name |
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
LIFESCAN, INC. |
1000 GIBRALTAR DR. |
MILPITAS,
CA
95035 -6312
|
|
Applicant Contact |
MARY ELLEN HOLDEN |
Correspondent |
LIFESCAN, INC. |
1000 GIBRALTAR DR. |
MILPITAS,
CA
95035 -6312
|
|
Correspondent Contact |
MARY ELLEN HOLDEN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/18/2004 |
Decision Date | 05/20/2005 |
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
|
|
|