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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number862.1390
Classification Product Code
CDA  
Date Received08/09/1990
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
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