← Product Code [MSJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ) · K925702

# NICHOLS APO B CHEMILUMINESCENCE ASSAY (K925702)

_Nichols Institute Diagnostics · MSJ · Dec 23, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K925702

## Device Facts

- **Applicant:** Nichols Institute Diagnostics
- **Product Code:** [MSJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ.md)
- **Decision Date:** Dec 23, 1992
- **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/K925702](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K925702)

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