Device Classification Name |
acid, uric, uricase (u.v.)
|
510(k) Number |
K875320 |
Device Name |
BIOTROL URIC ACID ENZYMATIQUE UV H.P. |
Applicant |
BIOTROL, USA, INC. |
5 GREAT VALLEY PKWY, SUITE 248 |
GREAT VALLEY CORP. CENTER |
MALVERN,
PA
19355
|
|
Applicant Contact |
ALLAN C MURPHY |
Correspondent |
BIOTROL, USA, INC. |
5 GREAT VALLEY PKWY, SUITE 248 |
GREAT VALLEY CORP. CENTER |
MALVERN,
PA
19355
|
|
Correspondent Contact |
ALLAN C MURPHY |
Regulation Number | 862.1775
|
Classification Product Code |
|
Date Received | 12/29/1987 |
Decision Date | 02/01/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|