Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart I — Hematology Reagents](/submissions/HE/subpart-i%E2%80%94hematology-reagents) → [21 CFR 864.8500](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8500) → JCF — Lymphocyte Separation Medium

# JCF · Lymphocyte Separation Medium

_Hematology · 21 CFR 864.8500 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF

## Overview

- **Product Code:** JCF
- **Device Name:** Lymphocyte Separation Medium
- **Regulation:** [21 CFR 864.8500](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8500)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood.

## 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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K911731](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K911731.md) | LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 15, 1992 | SESE |
| [K902445](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K902445.md) | LYMPHO SEP(TM) | Icn Biomedicals, Inc. | Aug 22, 1990 | SESE |
| [K891407](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K891407.md) | LEUCOPREP CELL SEPARATION TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 26, 1989 | SESE |
| [K874328](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K874328.md) | L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA | E.I. Dupont DE Nemours & Co., Inc. | Feb 16, 1988 | SESE |
| [K873185](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K873185.md) | DYNABEADS HLA CELL PREP II ISOLATION PRODUCT | Dynal Biotech, Inc. | Nov 4, 1987 | SESE |
| [K872775](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K872775.md) | LEUCOPREP BRAND TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 2, 1987 | SESE |
| [K860354](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K860354.md) | SEPRACELL LYMPHOCYTE SEPARATION MEDIUM | Sepratech Corporation C/O Keller and Heckman | Apr 18, 1986 | SESE |
| [K854093](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K854093.md) | LEUCO PREP | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 12, 1985 | SESE |
| [K842818](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K842818.md) | CST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 23, 1984 | SESE |
| [K842146](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K842146.md) | HISTOPAQUE-1077 | Sigma Chemical Co. | Jul 27, 1984 | SESE |
| [K812947](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K812947.md) | MONO-POLY RESOLVING MEDIUM | Flow Laboratories, Inc. | Mar 11, 1982 | SESE |
| [K812411](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K812411.md) | IMMUNO-CELL IMMUNO-SEP KIT | Kallestad Laboratories, Inc. | Nov 10, 1981 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 5 clearances
- Dynal Biotech, Inc. — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Flow Laboratories, Inc. — 1 clearance
- Icn Biomedicals, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF)

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