Device Classification Name |
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
|
510(k) Number |
K903609 |
Device Name |
SEROTONIN ENZYME IMMUNOASSAY |
Applicant |
IMMUNOTECH CORP. |
130, AVENUE JEAN DE LATTRE DE |
TASSIGNY-BP 177, 13276 MARSEIL |
CEDEX 9 (FRANCE),
FR
|
|
Applicant Contact |
RICKENBERG |
Correspondent |
IMMUNOTECH CORP. |
130, AVENUE JEAN DE LATTRE DE |
TASSIGNY-BP 177, 13276 MARSEIL |
CEDEX 9 (FRANCE),
FR
|
|
Correspondent Contact |
RICKENBERG |
Regulation Number | 862.1390
|
Classification Product Code |
|
Date Received | 08/09/1990 |
Decision Date | 10/22/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|