← Product Code [CGN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN) · K780508

# QUANTITOPE 125I-FOLATE RADIOASSAY KIT (K780508)

_Kallestad Laboratories, Inc. · CGN · May 3, 1978 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K780508

## Device Facts

- **Applicant:** Kallestad Laboratories, Inc.
- **Product Code:** [CGN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN.md)
- **Decision Date:** May 3, 1978
- **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/K780508](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K780508)

**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