← Product Code [GKJ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ) · K831558

# E-Z PREP (K831558)

_Coulter Electronics, Inc. · GKJ · Jun 16, 1983 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ/K831558

## Device Facts

- **Applicant:** Coulter Electronics, Inc.
- **Product Code:** [GKJ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ.md)
- **Decision Date:** Jun 16, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5850
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm).

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ/K831558](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ/K831558)

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