← Product Code [DFC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC) · K001933

# WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO (K001933)

_Wako Chemicals USA, Inc. · DFC · Jul 24, 2000 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K001933

## Device Facts

- **Applicant:** Wako Chemicals USA, Inc.
- **Product Code:** [DFC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC.md)
- **Decision Date:** Jul 24, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.5600
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K001933](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DFC/K001933)

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