Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K120558 |
Device Name |
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION |
Applicant |
LIFESCAN, INC. |
200 LAWRENCE DRIVE |
MAILSTOP C-2-2 |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
ANDREA TASKER |
Correspondent |
LIFESCAN, INC. |
200 LAWRENCE DRIVE |
MAILSTOP C-2-2 |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
ANDREA TASKER |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/24/2012 |
Decision Date | 02/07/2013 |
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
|
|
|