← Product Code [JGG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGG) · K895850

# SYNCHRON CX SYSTEMS (LAP) REAGENT KIT (K895850)

_Beckman Instruments, Inc. · JGG · Dec 5, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGG/K895850

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [JGG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGG.md)
- **Decision Date:** Dec 5, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1460
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A leucine aminopeptidase test system is a device intended to measure the activity of the enzyme leucine amino-peptidase in serum, plasma, and urine. Leucine aminopeptidase measurements are used in the diagnosis and treatment of liver diseases such as viral hepatitis and obstructive jaundice.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGG/K895850](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGG/K895850)

**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