Device Classification Name |
Urease And Glutamic Dehydrogenase, Urea Nitrogen
|
510(k) Number |
K974337 |
Device Name |
IL TEST UREA NITROGEN |
Applicant |
INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. |
LEXINGTON,
MA
02173
|
|
Applicant Contact |
CAROL MARBLE |
Correspondent |
INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. |
LEXINGTON,
MA
02173
|
|
Correspondent Contact |
CAROL MARBLE |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 11/18/1997 |
Decision Date | 12/17/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|