Device Classification Name |
urease and glutamic dehydrogenase, urea nitrogen
|
510(k) Number |
K894836 |
Device Name |
DART UREA NITROGEN |
Applicant |
COULTER ELECTRONICS, INC. |
745 WEST 83RD ST. |
HIALEAH,
FL
33014
|
|
Applicant Contact |
RICHARDSON-JONES |
Correspondent |
COULTER ELECTRONICS, INC. |
745 WEST 83RD ST. |
HIALEAH,
FL
33014
|
|
Correspondent Contact |
RICHARDSON-JONES |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 07/31/1989 |
Decision Date | 10/30/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|