Device Classification Name |
Urease And Glutamic Dehydrogenase, Urea Nitrogen
|
510(k) Number |
K770315 |
Device Name |
BUN, ENZYMATIC |
Applicant |
ICN PHARMACEUTICALS, INC. |
13 MOUNTAINVIEW AVE. |
ORANGEBURG,
NY
10962
|
|
Correspondent |
ICN PHARMACEUTICALS, INC. |
13 MOUNTAINVIEW AVE. |
ORANGEBURG,
NY
10962
|
|
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 02/16/1977 |
Decision Date | 04/05/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|