Device Classification Name |
Diacetyl-Monoxime, Urea Nitrogen
|
510(k) Number |
K844156 |
Device Name |
UREA NITROGEN REAGENT SET |
Applicant |
LIVONIA DIAGNOSTICS, INC. |
33041 W. EIGHT MILE RD. |
LIVONIA,
MI
48152
|
|
Applicant Contact |
WALTER H LAMBERT |
Correspondent |
LIVONIA DIAGNOSTICS, INC. |
33041 W. EIGHT MILE RD. |
LIVONIA,
MI
48152
|
|
Correspondent Contact |
WALTER H LAMBERT |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 10/24/1984 |
Decision Date | 11/13/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|