CDA · Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Clinical Chemistry · 21 CFR 862.1390 · Class 1
Overview
| Product Code | CDA |
|---|---|
| Device Name | Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin |
| Regulation | 21 CFR 862.1390 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952817 | BIO-RAD URINARY 5-HIAA BY HPLC | Bio-Rad | Aug 1, 1995 | SESE |
| K903609 | SEROTONIN ENZYME IMMUNOASSAY | Immunotech Corp. | Oct 22, 1990 | SESE |
| K854946 | TDXR 5-HIAA (URINE) | Abbott Laboratories | Jan 17, 1986 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- Bio-Rad — 1 clearance
- Immunotech Corp. — 1 clearance
