← Product Code [GKF](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF) · K880373

# IONOMETER E-HK AND ACCESSORIES (K880373)

_Smash Ent., Inc. · GKF · Mar 17, 1988 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K880373

## Device Facts

- **Applicant:** Smash Ent., Inc.
- **Product Code:** [GKF](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF.md)
- **Decision Date:** Mar 17, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5600
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K880373](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K880373)

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