← Product Code [GKH](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH) · K904795

# FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM (K904795)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · GKH · Dec 31, 1990 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K904795

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [GKH](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH.md)
- **Decision Date:** Dec 31, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5240
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K904795](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K904795)

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