Device Classification Name |
Urease And Glutamic Dehydrogenase, Urea Nitrogen
|
510(k) Number |
K002694 |
Device Name |
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 |
Applicant |
DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. |
CHARLOTTETOWN,
CA
C1E 2A6
|
|
Applicant Contact |
KAREN CALLBECK |
Correspondent |
DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. |
CHARLOTTETOWN,
CA
C1E 2A6
|
|
Correspondent Contact |
KAREN CALLBECK |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 08/29/2000 |
Decision Date | 09/15/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|