MODEL 5500 CEAS
Device Facts
| Record ID | K934977 |
|---|---|
| Device Name | MODEL 5500 CEAS |
| Applicant | Esa, Inc. |
| Product Code | CDF · Clinical Chemistry |
| Decision Date | Jan 11, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1795 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.
