JNP · Infrared Spectroscopy Measurement, Urinary Calculi (Stone)
Clinical Chemistry · 21 CFR 862.1780 · Class 1
Overview
| Product Code | JNP |
|---|---|
| Device Name | Infrared Spectroscopy Measurement, Urinary Calculi (Stone) |
| Regulation | 21 CFR 862.1780 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A urinary calculi (stones) test system is a device intended for the analysis of urinary calculi. Analysis of urinary calculi is used in the diagnosis and treatment of calculi of the urinary tract.
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.
