JGK · Ferric Chloride, Phenylketones (Urinary, Non-Quant.)
Clinical Chemistry · 21 CFR 862.1560 · Class 1
Overview
| Product Code | JGK |
|---|---|
| Device Name | Ferric Chloride, Phenylketones (Urinary, Non-Quant.) |
| Regulation | 21 CFR 862.1560 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A urinary phenylketones (nonquantitative) test system is a device intended to identify phenylketones (such as phenylpyruvic acid) in urine. The identification of urinary phenylketones is used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.
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.
Cleared Devices (0)
No cleared devices on record.
