Device Classification Name |
urease and glutamic dehydrogenase, urea nitrogen
|
510(k) Number |
K952742 |
Device Name |
BLOOD UREA NITROGEN REAGENT SYSTEM |
Applicant |
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
6025 NICOLLE ST. |
VENTURA,
CA
93003
|
|
Applicant Contact |
MICHAEL D BICK |
Correspondent |
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
6025 NICOLLE ST. |
VENTURA,
CA
93003
|
|
Correspondent Contact |
MICHAEL D BICK |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 06/16/1995 |
Decision Date | 08/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|