← Product Code [GKR](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR) · K945677

# IL682, CO-OXIMETER (K945677)

_Instrumentation Laboratory CO · GKR · Oct 20, 1995 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K945677

## Device Facts

- **Applicant:** Instrumentation Laboratory CO
- **Product Code:** [GKR](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR.md)
- **Decision Date:** Oct 20, 1995
- **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.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K945677](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKR/K945677)

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