Device Classification Name |
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
|
510(k) Number |
K843379 |
Device Name |
VMA ASSAY KIT |
Applicant |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
4 NEWLAND CRESCENT |
CHARLOTTETOWN |
CANADA,
|
|
Correspondent |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
4 NEWLAND CRESCENT |
CHARLOTTETOWN |
CANADA,
|
|
Regulation Number | 862.1795
|
Classification Product Code |
|
Date Received | 08/28/1984 |
Decision Date | 09/28/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|