← Product Code [CIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX) · K853868

# ALBUMIN SR LIQUID STABLE REAGENT SET (K853868)

_Medical Analysis Systems, Inc. · CIX · Sep 30, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K853868

## Device Facts

- **Applicant:** Medical Analysis Systems, Inc.
- **Product Code:** [CIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX.md)
- **Decision Date:** Sep 30, 1985
- **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/K853868](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIX/K853868)

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