Device Classification Name |
acid, uric, uricase (colorimetric)
|
510(k) Number |
K811810 |
Device Name |
URIC ACID TEST |
Applicant |
ENVIRONMENTAL CHEMICAL SPECIALTIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ENVIRONMENTAL CHEMICAL SPECIALTIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1775
|
Classification Product Code |
|
Date Received | 06/25/1981 |
Decision Date | 07/15/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|