Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K051213 |
Device Name |
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS |
Applicant |
ABBOTT LABORATORIES INC |
1360 SOUTH LOOP ROAD |
ALAMEDA,
CA
94502
|
|
Applicant Contact |
ANDREA RUTH |
Correspondent |
ABBOTT LABORATORIES INC |
1360 SOUTH LOOP ROAD |
ALAMEDA,
CA
94502
|
|
Correspondent Contact |
ANDREA RUTH |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/12/2005 |
Decision Date | 05/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|