BIO-RAD URINARY 5-HIAA BY HPLC
Device Facts
| Record ID | K952817 |
|---|---|
| Device Name | BIO-RAD URINARY 5-HIAA BY HPLC |
| Applicant | Bio-Rad |
| Product Code | CDA · Clinical Chemistry |
| Decision Date | Aug 1, 1995 |
| 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.
