Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K041478 |
Device Name |
BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR |
Applicant |
BECTON DICKINSON |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
JOHN SCHALAGO |
Correspondent |
BECTON DICKINSON |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
JOHN SCHALAGO |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 06/03/2004 |
Decision Date | 10/28/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|