← Product Code [DDS](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS) · K854811

# ICS PAB PREALBUMIN REAGENT TEST KIT (K854811)

_Beckman Instruments, Inc. · DDS · Jan 24, 1986 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS/K854811

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [DDS](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS.md)
- **Decision Date:** Jan 24, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5060
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS/K854811](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS/K854811)

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