JSE — Culture Media, Multiple Biochemical Test Class I

FDA Device Classification

Classification Details

Product Code
JSE
Device Class
Class I
Regulation Number
866.2320
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K962265dynatech laboratoriesMLX MICROTITER PLATE LUMINOMETERJuly 25, 1996
K883996pro-labX-ACT LDC/INDOctober 12, 1988
K883995pro-labX-ACT UREA/TDAOctober 12, 1988
K880133hardy mediaMIL MEDIUMMarch 31, 1988
K880116hardy mediaMRVP BROTHMarch 31, 1988
K874537lakewood biochemical coKLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGARNovember 20, 1987
K871096biomerieuxCYSTINE TRYPTIC AGAR W/O CARBOHYDRATESApril 3, 1987
K864674american micro scanMICRODILUTION IDENTIFICATION PANELSJanuary 5, 1987
K862393otisville biotechBIOTIS LITMUS MILKJuly 3, 1986
K860412otisville biotechBIOTIS SIM MEDIUMFebruary 24, 1986
K860415otisville biotechBIOTIS SIMMON CITRATE AGARFebruary 24, 1986
K860413otisville biotechBIOTIS TSIFebruary 24, 1986
K860414otisville biotechBIOTIS ORNITHINE INDOLE MOTILITY MEDIAFebruary 24, 1986
K860194austin biological laboratoriesAUSTIN ENTERIC SYSTEMFebruary 20, 1986
K850982analytical productsCTAPI - NEISSERA SCREENMarch 29, 1985
K850734roseville medical laboratoriesuDIFFERENTIAL CULTURE MEDIUMMarch 20, 1985
K850551hardy mediaSIM MEDIUMMarch 11, 1985
K850547hardy mediaMOTILITY INDOLE ORNITHINE AGARMarch 11, 1985
K850546hardy mediaKLIGLER IRON AGAR KIAMarch 11, 1985
K850548hardy mediaLYSINE IRON AGAR LIAMarch 11, 1985