← Product Code [JZJ](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZJ) · K851912

# LASER PREALBUMIN TEST (K851912)

_Behring Diagnostics, Inc. · JZJ · Jun 21, 1985 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZJ/K851912

## Device Facts

- **Applicant:** Behring Diagnostics, Inc.
- **Product Code:** [JZJ](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZJ.md)
- **Decision Date:** Jun 21, 1985
- **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/K851912](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZJ/K851912)

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