Device Classification Name |
Urease And Glutamic Dehydrogenase, Urea Nitrogen
|
510(k) Number |
K871547 |
Device Name |
ULTRA-VIOLET BUN REAGENT KIT (RATE) |
Applicant |
BIOCHEMICAL TRADE, INC. |
P.O. BOX 520575 |
MIAMI,
FL
33152
|
|
Applicant Contact |
ROY, PH.D. |
Correspondent |
BIOCHEMICAL TRADE, INC. |
P.O. BOX 520575 |
MIAMI,
FL
33152
|
|
Correspondent Contact |
ROY, PH.D. |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 04/20/1987 |
Decision Date | 06/22/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|