Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart C — Microbiology Devices](/submissions/MI/subpart-c%E2%80%94microbiology-devices) → [21 CFR 866.2850](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2850) → KZK — Reader, Zone, Automated

# KZK · Reader, Zone, Automated

_Microbiology · 21 CFR 866.2850 · Class 1_

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

## Overview

- **Product Code:** KZK
- **Device Name:** Reader, Zone, Automated
- **Regulation:** [21 CFR 866.2850](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2850)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## Identification

An automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc-agar diffusion antimicrobial susceptibility tests. The device aids in decisionmaking respecting the treatment of disease.

## Classification Rationale

Class I (general controls).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K991473](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZK/K991473.md) | SIRSCAN | Intelligence Artificielle Applications | Nov 23, 1999 | SESE |
| [K944319](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZK/K944319.md) | BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM | Giles Scientific, Inc. | Dec 15, 1994 | SESE |
| [K932122](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZK/K932122.md) | BIOMIC VIDEO PLATE READER | Giles Scientific, Inc. | Mar 1, 1994 | SESE |

## Top Applicants

- Giles Scientific, Inc. — 2 clearances
- Intelligence Artificielle Applications — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com