Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart C — Microbiology Devices](/submissions/MI/subpart-c%E2%80%94microbiology-devices) → [21 CFR 866.2170](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2170) → KZB — Automated Colony Counter

# KZB · Automated Colony Counter

_Microbiology · 21 CFR 866.2170 · Class 1_

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

## Overview

- **Product Code:** KZB
- **Device Name:** Automated Colony Counter
- **Regulation:** [21 CFR 866.2170](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2170)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K893519](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZB/K893519.md) | TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF | Statlabs, Inc. | Aug 15, 1989 | SESE |

## Top Applicants

- Statlabs, Inc. — 1 clearance

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

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