Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K963500 |
Device Name |
GLUCOMETER DEX DIABETES CARE SYSTEM |
Applicant |
BAYER CORP. |
1884 MILES AVE. |
ELKHART,
IN
46514
|
|
Applicant Contact |
ROSANNE M SAVOL, R.A.C. |
Correspondent |
BAYER CORP. |
1884 MILES AVE. |
ELKHART,
IN
46514
|
|
Correspondent Contact |
ROSANNE M SAVOL, R.A.C. |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 09/03/1996 |
Decision Date | 01/21/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|