SEROTONIN ENZYME IMMUNOASSAY
Device Facts
| Record ID | K903609 |
|---|---|
| Device Name | SEROTONIN ENZYME IMMUNOASSAY |
| Applicant | Immunotech Corp. |
| Product Code | CDA · Clinical Chemistry |
| Decision Date | Oct 22, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1390 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine tissue.
