← Product Code [CGX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX) · K802156

# REAGENTS SERUM CREATINE USING TECHICON (K802156)

_Panmed, Inc. · CGX · Oct 10, 1980 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K802156

## Device Facts

- **Applicant:** Panmed, Inc.
- **Product Code:** [CGX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX.md)
- **Decision Date:** Oct 10, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1225
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K802156](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGX/K802156)

**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