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510(k) K903609

SEROTONIN ENZYME IMMUNOASSAY by Immunotech Corp. — Product Code CDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1990
Date Received
August 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Device Class
Class I
Regulation Number
862.1390
Review Panel
CH
Submission Type

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