Lymphocyte Separation Medium
FDA product code JCF · Class I (low risk) · 21 CFR 864.8500 · Hematology
12510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911731 | Leucoprep(R) Brand Cell Separat Tube W/Sodium CitrJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/15/1992SE |
| K902445 | Lympho Sep(Tm)JCF · Traditional | Icn Biomedicals, Inc. | 08/22/1990SE |
| K891407 | Leucoprep Cell Separation TubeJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/26/1989SE |
| K874328 | L-Phenylalanine Methyl Ester Hydrochloride Pme ReaJCF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 02/16/1988SE |
| K873185 | Dynabeads Hla Cell Prep II Isolation ProductJCF · Traditional | Dynal Biotech, Inc. | 11/04/1987SE |
| K872775 | Leucoprep Brand TubeJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/02/1987SE |
| K860354 | Sepracell Lymphocyte Separation MediumJCF · Traditional | Sepratech Corporation C/O Keller and Heckman | 04/18/1986SE |
| K854093 | Leuco PrepJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/12/1985SE |
| K842818 | CSTJCF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/23/1984SE |
| K842146 | HISTOPAQUE-1077JCF · Traditional | Sigma Chemical Co. | 07/27/1984SE |
| K812947 | Mono-Poly Resolving MediumJCF · Traditional | Flow Laboratories, Inc. | 03/11/1982SE |
| K812411 | Immuno-Cell Immuno-Sep KitJCF · Traditional | Kallestad Laboratories, Inc. | 11/10/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2542-2014 Class II | BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog…BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in… | Becton Dickinson & Company | 07/03/2014Terminated |
| Z-0977-2010 | Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl…Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain… | Sigma-Aldrich Mfg LLC | 12/08/2009Terminated |
| Z-0976-2010 | Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls. and a…Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain… | Sigma-Aldrich Mfg LLC | 12/08/2009Terminated |
| Z-0974-2010 | Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on…Some of the product was contaminated with Pseudomonas mendocina | Sigma-Aldrich Mfg LLC | 09/04/2009Terminated |