Device Classification Name |
Urease And Glutamic Dehydrogenase, Urea Nitrogen
|
510(k) Number |
K993178 |
Device Name |
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 |
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 | 09/23/1999 |
Decision Date | 10/18/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|