← Product Code [GIF](/productcode/GIF) · K821683

# REAGENT FOR COULTER COUNTER MODEL 5+11 (K821683)

_Fisher Scientific Co., LLC · GIF · Jun 24, 1982 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K821683

## Device Facts

- **Applicant:** Fisher Scientific Co., LLC
- **Product Code:** [GIF](/productcode/GIF.md)
- **Decision Date:** Jun 24, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8200
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.

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**Source:** [https://fda-staging.innolitics.com/device/K821683](https://fda-staging.innolitics.com/device/K821683)

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