Device Classification Name |
Urease And Glutamic Dehydrogenase, Urea Nitrogen
|
510(k) Number |
K852292 |
Device Name |
DURAZYME UREA NITROGEN |
Applicant |
AMERICAN MONITOR CORP. |
P.O. BOX 68505 |
INDIANAPOLIS,
IN
46268
|
|
Applicant Contact |
LINDA M CHINN |
Correspondent |
AMERICAN MONITOR CORP. |
P.O. BOX 68505 |
INDIANAPOLIS,
IN
46268
|
|
Correspondent Contact |
LINDA M CHINN |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 05/29/1985 |
Decision Date | 07/08/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|