Device Classification Name |
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
|
510(k) Number |
K830340 |
Device Name |
FITKIT I CHECKUP KIT |
Applicant |
BODITESTOR |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BODITESTOR |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1785 |
Classification Product Code |
|
Date Received | 02/02/1983 |
Decision Date | 08/16/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|