← Product Code [MSJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ) · K912749

# REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B (K912749)

_Medical Analysis Systems, Inc. · MSJ · Sep 23, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K912749

## Device Facts

- **Applicant:** Medical Analysis Systems, Inc.
- **Product Code:** [MSJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ.md)
- **Decision Date:** Sep 23, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1475
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K912749](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K912749)

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