Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K943241 |
Device Name |
DMA GLUCOSE (OXIDASE) PROCEDURE |
Applicant |
DATA MEDICAL ASSOCIATES, INC. |
845 AVENUE G EAST |
ARLINGTON,
TX
76011
|
|
Applicant Contact |
ANNETTE T WELLS |
Correspondent |
DATA MEDICAL ASSOCIATES, INC. |
845 AVENUE G EAST |
ARLINGTON,
TX
76011
|
|
Correspondent Contact |
ANNETTE T WELLS |
Regulation Number | 862.1345 |
Classification Product Code |
|
Date Received | 07/06/1994 |
Decision Date | 10/20/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|