← Product Code [JZJ](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZJ) · K000661

# RANDOX PREALBUMIN (K000661)

_Randox Laboratories, Ltd. · JZJ · Apr 13, 2000 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZJ/K000661

## Device Facts

- **Applicant:** Randox Laboratories, Ltd.
- **Product Code:** [JZJ](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZJ.md)
- **Decision Date:** Apr 13, 2000
- **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/JZJ/K000661](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZJ/K000661)

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