JCF · Class I · 21 CFR 864.8500

FDA Product Code JCF: Lymphocyte Separation Medium

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Kallestad Laboratories, Inc. and Flow Laboratories, Inc..

12
Total
12
Cleared
128d
Avg days
1981
Since

FDA 510(k) Cleared Lymphocyte Separation Medium Devices (Product Code JCF)

12 devices
1–12 of 12
Cleared Dec 15, 1992
LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
K911731
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 608d
Cleared May 26, 1989
LEUCOPREP CELL SEPARATION TUBE
K891407
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 73d
Cleared Feb 16, 1988
L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
K874328
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 117d
Cleared Oct 02, 1987
LEUCOPREP BRAND TUBE
K872775
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 80d
Cleared Nov 12, 1985
LEUCO PREP
K854093
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 36d
Cleared Oct 23, 1984
CST
K842818
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 97d
Cleared Jul 27, 1984
HISTOPAQUE-1077
K842146
Sigma Chemical Co.
Hematology · 58d
Cleared Mar 11, 1982
MONO-POLY RESOLVING MEDIUM
K812947
Flow Laboratories, Inc.
Hematology · 142d
Cleared Nov 10, 1981
IMMUNO-CELL IMMUNO-SEP KIT
K812411
Kallestad Laboratories, Inc.
Hematology · 81d

About Product Code JCF - Regulatory Context