← Product Code [MSJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ) · K864228

# APO B., IMMUNOTURBIDIMETRIC ASSAY (K864228)

_Intl. Diagnostic Laboratories, Ltd. · MSJ · Mar 12, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K864228

## Device Facts

- **Applicant:** Intl. Diagnostic Laboratories, Ltd.
- **Product Code:** [MSJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ.md)
- **Decision Date:** Mar 12, 1987
- **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/K864228](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/MSJ/K864228)

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