← Product Code [MSJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ) · K881898

# MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B (K881898)

_Atlantic Antibodies · MSJ · Jun 14, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K881898

## Device Facts

- **Applicant:** Atlantic Antibodies
- **Product Code:** [MSJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ.md)
- **Decision Date:** Jun 14, 1988
- **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/K881898](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K881898)

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