Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K951537 |
Device Name |
GLUCOMETER ELITE M BLOOD GLUCOSE METER |
Applicant |
BAYER CORP. |
P.O. BOX 2004 |
ROUTE 70 EAST |
MISHAWAKA,
IN
46546 -2004
|
|
Applicant Contact |
ROSANNE M SAVOL |
Correspondent |
BAYER CORP. |
P.O. BOX 2004 |
ROUTE 70 EAST |
MISHAWAKA,
IN
46546 -2004
|
|
Correspondent Contact |
ROSANNE M SAVOL |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 04/03/1995 |
Decision Date | 07/14/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|