← Product Code [DEL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEL) · K893885

# BACTON TM, BASIC TM, APO A-I REAGENT (K893885)

_Catachem, Inc. · DEL · Jun 21, 1989 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DEL/K893885

## Device Facts

- **Applicant:** Catachem, Inc.
- **Product Code:** [DEL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEL.md)
- **Decision Date:** Jun 21, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5590
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high-density lipoprotein) in serum and other body fluids. Measurement of lipoprotein X aids in the diagnosis of obstructive liver disease.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DEL/K893885](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DEL/K893885)

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