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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, Ave. Jean De Lattre De
Tassigny-Bp 177, 13276 Marseil
Cedex 9 (France),  FR
Applicant Contact RICKENBERG
Correspondent
Immunotech Corp.
130, Ave. 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
Predetermined Change
Control Plan Authorized		 No
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