Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K073231 |
Device Name |
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
LIFESCAN, INC. |
1000 GIBRALTAR DR. |
MILPITAS,
CA
95035 -6312
|
|
Applicant Contact |
KIM FONDA |
Correspondent |
LIFESCAN, INC. |
1000 GIBRALTAR DR. |
MILPITAS,
CA
95035 -6312
|
|
Correspondent Contact |
KIM FONDA |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/15/2007 |
Decision Date | 04/18/2008 |
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
|
|
|