Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K010553 |
Device Name |
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY |
Applicant |
ABBOTT LABORATORIES |
4-A CROSBY DR. |
BEDFORD,
MA
01730 -1402
|
|
Applicant Contact |
JANET CONNOLLY |
Correspondent |
ABBOTT LABORATORIES |
4-A CROSBY DR. |
BEDFORD,
MA
01730 -1402
|
|
Correspondent Contact |
JANET CONNOLLY |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/26/2001 |
Decision Date | 06/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|