# MKQ · Processor, Cervical Cytology Slide, Automated

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/MKQ

## Overview

- **Product Code:** MKQ
- **Device Name:** Processor, Cervical Cytology Slide, Automated
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer.  The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide.  They are stained and screened by a cytotechnologist and cytopathologist.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P040052](/device/P040052.md) | MONOPREP PAP TEST | Hologic, Inc. | Mar 3, 2006 | APWD |
| [P970018](/device/P970018.md) | BD PREPSTAIN SYSTEM | Bd Diagnostic Systems | Jun 17, 1999 | APPR |
| [P950039](/device/P950039.md) | THINPREP(R) PROCESSOR, MODEL TP 2000 | Hologic, Inc. | May 20, 1996 | APPR |

## Top Applicants

- Hologic, Inc. — 2 clearances
- Bd Diagnostic Systems — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/MKQ](https://fda.innolitics.com/productcode/MKQ)

**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