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JCF — Lymphocyte Separation Medium Class I

FDA Device Classification

Classification Details

Product Code
JCF
Device Class
Class I
Regulation Number
864.8500
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K911731bd becton dickinson vacutainer systems preanalyticLEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITRDecember 15, 1992
K902445icn biomedicalsLYMPHO SEP(TM)August 22, 1990
K891407bd becton dickinson vacutainer systems preanalyticLEUCOPREP CELL SEPARATION TUBEMay 26, 1989
K874328e.i. dupont de nemours and coL-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REAFebruary 16, 1988
K873185dynal biotechDYNABEADS HLA CELL PREP II ISOLATION PRODUCTNovember 4, 1987
K872775bd becton dickinson vacutainer systems preanalyticLEUCOPREP BRAND TUBEOctober 2, 1987
K860354sepratech corporation c/o keller and heckmanSEPRACELL LYMPHOCYTE SEPARATION MEDIUMApril 18, 1986
K854093bd becton dickinson vacutainer systems preanalyticLEUCO PREPNovember 12, 1985
K842818bd becton dickinson vacutainer systems preanalyticCSTOctober 23, 1984
K842146sigma chemicalHISTOPAQUE-1077July 27, 1984
K812947flow laboratoriesMONO-POLY RESOLVING MEDIUMMarch 11, 1982
K812411kallestad laboratoriesIMMUNO-CELL IMMUNO-SEP KITNovember 10, 1981