Device Classification Name |
urease and glutamic dehydrogenase, urea nitrogen
|
510(k) Number |
K901123 |
Device Name |
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN |
Applicant |
TECHNICON INSTRUMENTS CORP. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
THOMAS C BREWSTER |
Correspondent |
TECHNICON INSTRUMENTS CORP. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
THOMAS C BREWSTER |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 03/12/1990 |
Decision Date | 05/10/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|