Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K123089 |
Device Name |
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 |
Applicant |
ABBOTT LABORATORIES |
1360 SOUTH LOOP ROAD |
ALAMEDA,
CA
94502
|
|
Applicant Contact |
DAVID G LAMBERT |
Correspondent |
ABBOTT LABORATORIES |
1360 SOUTH LOOP ROAD |
ALAMEDA,
CA
94502
|
|
Correspondent Contact |
DAVID G LAMBERT |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/01/2012 |
Decision Date | 04/05/2013 |
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
|
|
|