← Product Code [GKL](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKL) · K001683

# SYSMEX R-500 (K001683)

_Sysmex Corporation of America · GKL · Aug 21, 2000 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKL/K001683

## Device Facts

- **Applicant:** Sysmex Corporation of America
- **Product Code:** [GKL](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKL.md)
- **Decision Date:** Aug 21, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5200
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKL/K001683](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKL/K001683)

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