JOA · Acid, Trifluoroacetic, Vitamin A, Hexane Extraction
Clinical Chemistry · 21 CFR 862.1805 · Class 1
Overview
| Product Code | JOA |
|---|---|
| Device Name | Acid, Trifluoroacetic, Vitamin A, Hexane Extraction |
| Regulation | 21 CFR 862.1805 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A vitamin A test system is a device intended to measure vitamin A in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin A deficiency conditions, including night blindness, or skin, eye, or intestinal disorders.
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.
