← Product Code [GKR](/productcode/GKR) · K781361

# HEMOGLOBINOMETER MODEL 720 B (K781361)

_Innovative Medical Systems, Inc. · GKR · Sep 14, 1978 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K781361

## Device Facts

- **Applicant:** Innovative Medical Systems, Inc.
- **Product Code:** [GKR](/productcode/GKR.md)
- **Decision Date:** Sep 14, 1978
- **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.

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**Source:** [https://fda-staging.innolitics.com/device/K781361](https://fda-staging.innolitics.com/device/K781361)

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