← Product Code [CIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX) · K822471

# PSI ALBUMIN REAGENT (K822471)

_Pointe Scientific, Inc., · CIX · Sep 14, 1982 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K822471

## Device Facts

- **Applicant:** Pointe Scientific, Inc.,
- **Product Code:** [CIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX.md)
- **Decision Date:** Sep 14, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1035
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K822471](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K822471)

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