Device Classification Name |
acid, uric, uricase (u.v.)
|
510(k) Number |
K981189 |
Device Name |
URIC ACID |
Applicant |
ABBOTT LABORATORIES |
DEPT. 09VA LC-2 |
1920 HURD DRIVE |
IRVING,
TX
75038
|
|
Applicant Contact |
MARK LITTLEFIELD |
Correspondent |
ABBOTT LABORATORIES |
DEPT. 09VA LC-2 |
1920 HURD DRIVE |
IRVING,
TX
75038
|
|
Correspondent Contact |
MARK LITTLEFIELD |
Regulation Number | 862.1775
|
Classification Product Code |
|
Date Received | 04/02/1998 |
Decision Date | 05/07/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|