← Product Code [JZW](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW) · K001647

# BN PROSPEC SYSTEM (K001647)

_Dade Behring, Inc. · JZW · Sep 26, 2000 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K001647

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [JZW](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW.md)
- **Decision Date:** Sep 26, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.4540
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

Immunonephelometer equipment for clinical use with its electrical power supply is a device that measures light scattering from antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light passed through a solution is scattered by the particles in suspension. The amount of light is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is called the light-scattering value and is used to measure the concentration of antigen-antibody complexes. This generic type of device includes devices with various kinds of light sources, such as laser equipment.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K001647](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K001647)

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