JCF · Lymphocyte Separation Medium
Hematology · 21 CFR 864.8500 · Class 1
Overview
| Product Code | JCF |
|---|---|
| Device Name | Lymphocyte Separation Medium |
| Regulation | 21 CFR 864.8500 |
| Device Class | Class 1 |
| Review Panel | Hematology |
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 | LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 15, 1992 | SESE |
| K902445 | LYMPHO SEP(TM) | Icn Biomedicals, Inc. | Aug 22, 1990 | SESE |
| K891407 | LEUCOPREP CELL SEPARATION TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 26, 1989 | SESE |
| K874328 | L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA | E.I. Dupont DE Nemours & Co., Inc. | Feb 16, 1988 | SESE |
| K873185 | DYNABEADS HLA CELL PREP II ISOLATION PRODUCT | Dynal Biotech, Inc. | Nov 4, 1987 | SESE |
| K872775 | LEUCOPREP BRAND TUBE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 2, 1987 | SESE |
| K860354 | SEPRACELL LYMPHOCYTE SEPARATION MEDIUM | Sepratech Corporation C/O Keller and Heckman | Apr 18, 1986 | SESE |
| K854093 | LEUCO PREP | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 12, 1985 | SESE |
| K842818 | CST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 23, 1984 | SESE |
| K842146 | HISTOPAQUE-1077 | Sigma Chemical Co. | Jul 27, 1984 | SESE |
| K812947 | MONO-POLY RESOLVING MEDIUM | Flow Laboratories, Inc. | Mar 11, 1982 | SESE |
| K812411 | 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
