Device Classification Name |
Urease And Glutamic Dehydrogenase, Urea Nitrogen
|
510(k) Number |
K863260 |
Device Name |
BLOOD UREA NITROGEN(BUN) PROCEDURE |
Applicant |
DATA MEDICAL ASSOCIATES, INC. |
845 AVENUE G EAST |
ARLINGTON,
TX
76011
|
|
Applicant Contact |
MARJORIE B POTTS |
Correspondent |
DATA MEDICAL ASSOCIATES, INC. |
845 AVENUE G EAST |
ARLINGTON,
TX
76011
|
|
Correspondent Contact |
MARJORIE B POTTS |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 08/25/1986 |
Decision Date | 09/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|