FDA 510(k) Applications for Medical Device Product Code "JCF"
(Lymphocyte Separation Medium)

FDA 510(k) Number Applicant Device Name Decision Date
K842818 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC CST 10/23/1984
K854093 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC LEUCO PREP 11/12/1985
K872775 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC LEUCOPREP BRAND TUBE 10/02/1987
K891407 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC LEUCOPREP CELL SEPARATION TUBE 05/26/1989
K911731 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR 12/15/1992
K873185 DYNAL BIOTECH, INC. DYNABEADS HLA CELL PREP II ISOLATION PRODUCT 11/04/1987
K874328 E.I. DUPONT DE NEMOURS & CO., INC. L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA 02/16/1988
K812947 FLOW LABORATORIES, INC. MONO-POLY RESOLVING MEDIUM 03/11/1982
K902445 ICN BIOMEDICALS, INC. LYMPHO SEP(TM) 08/22/1990
K812411 KALLESTAD LABORATORIES, INC. IMMUNO-CELL IMMUNO-SEP KIT 11/10/1981
K860354 SEPRATECH CORPORATION C/O KELLER AND HECKMAN SEPRACELL LYMPHOCYTE SEPARATION MEDIUM 04/18/1986
K842146 SIGMA CHEMICAL CO. HISTOPAQUE-1077 07/27/1984


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