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 862.1145](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1145) → CHC — Titrimetric Permanganate And Bromophenol Blue, Calcium

# CHC · Titrimetric Permanganate And Bromophenol Blue, Calcium

_Clinical Chemistry · 21 CFR 862.1145 · Class 2_

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

## Overview

- **Product Code:** CHC
- **Device Name:** Titrimetric Permanganate And Bromophenol Blue, Calcium
- **Regulation:** [21 CFR 862.1145](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1145)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

## Classification Rationale

Class II.

## 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/CHC](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHC)

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