← Product Code [KZB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZB) · K893519

# TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF (K893519)

_Statlabs, Inc. · KZB · Aug 15, 1989 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZB/K893519

## Device Facts

- **Applicant:** Statlabs, Inc.
- **Product Code:** [KZB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZB.md)
- **Decision Date:** Aug 15, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2170
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

An automated colony counter is a mechanical device intended for medical purposes to determine the number of bacterial colonies present on a bacteriological culture medium contained in a petri plate. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZB/K893519](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZB/K893519)

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