Device Classification Name |
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
|
510(k) Number |
K772151 |
Device Name |
URINARY VMA - SCREEN TEST KIT |
Applicant |
EPPENDORF-BRINKMANN, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
EPPENDORF-BRINKMANN, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1795
|
Classification Product Code |
|
Date Received | 11/15/1977 |
Decision Date | 11/30/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|