Product Code: JCF FDA class 1 21 CFR 864.8500

Lymphocyte Separation Medium

Hematology

A lymphocyte separation medium is a density gradient reagent used in hematology and immunology laboratories to isolate mononuclear cells, particularly lymphocytes and monocytes, from whole blood through centrifugation, enabling downstream cellular analysis and testing. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is JCF, regulated under 21 CFR 864.8500, within the Hematology medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: JCF
Device Class: FDA class 1
Regulation Number: 864.8500
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 12 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K911731	LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR	Dec 15, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K902445	LYMPHO SEP(TM)	Aug 22, 1990	Substantially Equivalent	Icn Biomedicals, Inc.
K891407	LEUCOPREP CELL SEPARATION TUBE	May 26, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K874328	L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA	Feb 16, 1988	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K873185	DYNABEADS HLA CELL PREP II ISOLATION PRODUCT	Nov 04, 1987	Substantially Equivalent	Dynal Biotech, Inc.
K872775	LEUCOPREP BRAND TUBE	Oct 02, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K860354	SEPRACELL LYMPHOCYTE SEPARATION MEDIUM	Apr 18, 1986	Substantially Equivalent	Sepratech Corporation C/O Keller and Heckman
K854093	LEUCO PREP	Nov 12, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K842818	CST	Oct 23, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K842146	HISTOPAQUE-1077	Jul 27, 1984	Substantially Equivalent	Sigma Chemical Co.
K812947	MONO-POLY RESOLVING MEDIUM	Mar 11, 1982	Substantially Equivalent	Flow Laboratories, Inc.
K812411	IMMUNO-CELL IMMUNO-SEP KIT	Nov 10, 1981	Substantially Equivalent	Kallestad Laboratories, Inc.