Device Classification Name |
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
|
510(k) Number |
K852611 |
Device Name |
TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE |
Applicant |
MILES LABORATORIES, INC. |
1127 MYRTLE ST. |
P.O. BOX 40 |
ELKHART,
IN
46514
|
|
Applicant Contact |
JOHN H ENGELMANN |
Correspondent |
MILES LABORATORIES, INC. |
1127 MYRTLE ST. |
P.O. BOX 40 |
ELKHART,
IN
46514
|
|
Correspondent Contact |
JOHN H ENGELMANN |
Regulation Number | 862.1785
|
Classification Product Code |
|
Date Received | 06/19/1985 |
Decision Date | 09/03/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|