Device Classification Name |
acid, vanilmandelic, diazo, p-nitroaniline/vanillin
|
510(k) Number |
K861010 |
Device Name |
VMA BY HPLC TEST (VANILMANDELIC ACID) |
Applicant |
BIO-RAD |
2400 WRIGHT AVE. |
RICHMOND,
CA
94804
|
|
Applicant Contact |
FRANK MATARRESE |
Correspondent |
BIO-RAD |
2400 WRIGHT AVE. |
RICHMOND,
CA
94804
|
|
Correspondent Contact |
FRANK MATARRESE |
Regulation Number | 862.1795
|
Classification Product Code |
|
Date Received | 03/18/1986 |
Decision Date | 05/01/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|