Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K961337 |
Device Name |
EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM |
Applicant |
MEDISENSE, INC. |
266 SECOND AVE. |
WALTHAM,
MA
02154
|
|
Applicant Contact |
DAVID WONG |
Correspondent |
MEDISENSE, INC. |
266 SECOND AVE. |
WALTHAM,
MA
02154
|
|
Correspondent Contact |
DAVID WONG |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 04/08/1996 |
Decision Date | 06/21/1996 |
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
|
|
|