← Product Code [LBR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR) · K890023

# HDL CHOLESTEROL REAGENT (PTA/MGCL2) (K890023)

_Sigma Diagnostics, Inc. · LBR · Feb 17, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K890023

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [LBR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR.md)
- **Decision Date:** Feb 17, 1989
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K890023](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LBR/K890023)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com