Device Classification Name |
Urease And Glutamic Dehydrogenase, Urea Nitrogen
|
510(k) Number |
K851513 |
Device Name |
ULTRA-VIOLET BUN REAGENT KIT |
Applicant |
BIO-ANALYTICS LABORATORIES, INC. |
ONE BIO-ANALYTICS PLACE |
BOX 333 |
PALM CITY,
FL
33490
|
|
Applicant Contact |
ROY |
Correspondent |
BIO-ANALYTICS LABORATORIES, INC. |
ONE BIO-ANALYTICS PLACE |
BOX 333 |
PALM CITY,
FL
33490
|
|
Correspondent Contact |
ROY |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 04/15/1985 |
Decision Date | 05/20/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|