← Product Code [CFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL) · K831073

# DAC-CEL HCG-MCA KIT RD52 (K831073)

_Wellcome Diagnostics · CFL · Sep 1, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K831073

## Device Facts

- **Applicant:** Wellcome Diagnostics
- **Product Code:** [CFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL.md)
- **Decision Date:** Sep 1, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1370
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K831073](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K831073)

**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