Device Classification Name |
urease and glutamic dehydrogenase, urea nitrogen
|
510(k) Number |
K923506 |
Device Name |
UREA KIT |
Applicant |
RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD |
CRUMLIN, BT29 4QY CO. |
ANTRIM, N. IRELAND,
IR
|
|
Applicant Contact |
John Lamont |
Correspondent |
RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD |
CRUMLIN, BT29 4QY CO. |
ANTRIM, N. IRELAND,
IR
|
|
Correspondent Contact |
John Lamont |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 07/15/1992 |
Decision Date | 09/27/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|