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) → JFN — Atomic Absorption, Calcium

# JFN · Atomic Absorption, 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/JFN

## Overview

- **Product Code:** JFN
- **Device Name:** Atomic Absorption, 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K914510](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFN/K914510.md) | CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY | Beckman Instruments, Inc. | Nov 19, 1991 | SESE |
| [K871903](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFN/K871903.md) | QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL) | Creative Scientific Technology, Inc. | Sep 2, 1987 | SESE |
| [K770570](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFN/K770570.md) | CALCIUM/MAGNESIUM ANALYZER | Beckman Instruments, Inc. | Jun 8, 1977 | SESE |

## Top Applicants

- Beckman Instruments, Inc. — 2 clearances
- Creative Scientific Technology, Inc. — 1 clearance

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

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