Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K011240 |
Device Name |
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060 -4486
|
|
Applicant Contact |
STACEY L BOLEN |
Correspondent |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060 -4486
|
|
Correspondent Contact |
STACEY L BOLEN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/23/2001 |
Decision Date | 09/13/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|