Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1780](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1780) → JNP — Infrared Spectroscopy Measurement, Urinary Calculi (Stone)

# JNP · Infrared Spectroscopy Measurement, Urinary Calculi (Stone)

_Clinical Chemistry · 21 CFR 862.1780 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNP

## Overview

- **Product Code:** JNP
- **Device Name:** Infrared Spectroscopy Measurement, Urinary Calculi (Stone)
- **Regulation:** [21 CFR 862.1780](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1780)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNP](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNP)

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