← Product Code [CGN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN) · K812979

# VITAMIN B12/FOLATE DUAL RADIOASSAY KITS (K812979)

_Amersham Corp. · CGN · Nov 24, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K812979

## Device Facts

- **Applicant:** Amersham Corp.
- **Product Code:** [CGN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN.md)
- **Decision Date:** Nov 24, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1295
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K812979](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K812979)

**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