← Product Code [GKR](/productcode/GKR) · K812127

# KING DIAGNOSTICS HEMOGLOBIN TEST (K812127)

_King Diagnostics, Inc. · GKR · Aug 25, 1981 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K812127

## Device Facts

- **Applicant:** King Diagnostics, Inc.
- **Product Code:** [GKR](/productcode/GKR.md)
- **Decision Date:** Aug 25, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5620
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

---

**Source:** [https://fda-staging.innolitics.com/device/K812127](https://fda-staging.innolitics.com/device/K812127)

**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