CDK · Acid, Vanilmandelic, Electrophoretic Separation
Clinical Chemistry · 21 CFR 862.1795 · Class 1
Overview
| Product Code | CDK |
|---|---|
| Device Name | Acid, Vanilmandelic, Electrophoretic Separation |
| Regulation | 21 CFR 862.1795 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
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 (0 of 0)
No cleared devices on record.
