PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM
Device Facts
| Record ID | K953077 |
|---|---|
| Device Name | PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM |
| Applicant | Beckman Instruments, Inc. |
| Product Code | CDF · Clinical Chemistry |
| Decision Date | Jan 5, 1996 |
| 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.
