← Product Code [DDS](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS) · K934966

# SPQ PAL CONTROL LEVEL II (K934966)

_Incstar Corp. · DDS · Jan 11, 1994 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS/K934966

## Device Facts

- **Applicant:** Incstar Corp.
- **Product Code:** [DDS](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS.md)
- **Decision Date:** Jan 11, 1994
- **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/K934966](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS/K934966)

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