Browse hierarchy: [Pathology (PA)](/submissions/PA) → [Subpart D — Pathology Instrumentation and Accessories](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories) → [21 CFR 864.3300](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3300) → IFB — Cytocentrifuge

# IFB · Cytocentrifuge

_Pathology · 21 CFR 864.3300 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IFB

## Overview

- **Product Code:** IFB
- **Device Name:** Cytocentrifuge
- **Regulation:** [21 CFR 864.3300](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/864.3300)
- **Device Class:** 1
- **Review Panel:** [Pathology](/submissions/PA)

## Identification

A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g., cerebrospinal fluid) and to deposit these cells on a glass microscope slide for cytological examination.

## Classification Rationale

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K852117](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IFB/K852117.md) | CYTO-TEK CENTRIFUGE | Miles Laboratories, Inc. | Jun 10, 1985 | SESE |
| [K810848](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IFB/K810848.md) | CYTOBUCKET MODEL 1024 | Cytochem, Inc. | Apr 23, 1981 | SESE |
| [K792032](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IFB/K792032.md) | LEIF CENTRIFUGAL CYTOLOGY BUCKET | Robert C. Leif, Ph.D. | Nov 30, 1979 | SESE |

## Top Applicants

- Cytochem, Inc. — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
- Robert C. Leif, Ph.D. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IFB](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IFB)

**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