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KZJ — Device, Gas Generating Class I

FDA Device Classification

Classification Details

Product Code
KZJ
Device Class
Class I
Regulation Number
866.2580
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K881502fairleigh dickinson laboratoriesBREWER GEL FOR CAMPYLOBACTERApril 27, 1988
K875362fairleigh dickinson laboratoriesBREWER GEL FOR ANAEROBESJanuary 27, 1988
K872782bd becton dickinson vacutainer systems preanalyticBBL(R) GASPAK CO2 POUCH(TM)August 6, 1987
K871709difco laboratoriesANAEROBIC TRANSPORT POUCH (CATALYST-FREE)May 15, 1987
K871238scott laboratoriesANABAGApril 3, 1987
K862123marion laboratoriesBIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICEJune 16, 1986
K853534bd becton dickinson vacutainer systems preanalyticBBL CAMPY POUCHAugust 29, 1985
K845008marion laboratoriesBIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATEMarch 5, 1985
K844571bd becton dickinson vacutainer systems preanalyticCAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGEJanuary 30, 1985
K841117bd becton dickinson vacutainer systems preanalyticGASPAK PLUS DISPOS. HYDROGEN &April 4, 1984
K832229bd becton dickinson vacutainer systems preanalyticBBL ANAGEL POWDERAugust 12, 1983
K820308flow laboratoriesANA-DISC SYSTEMMarch 4, 1982
K820010oxoid u.s.aGAS GENERATING KIT, CO2January 28, 1982
K811957bd becton dickinson vacutainer systems preanalyticCAMPYPAKJuly 23, 1981
K802494oxoid u.s.aGAS GENERATING KIT SYSTEM FOR CAMPYLOB.November 12, 1980
K800899miles laboratoriesLAB-TEK ANACULT ANAEROBIC CULTURE CHAMBEMay 23, 1980
K800796bd becton dickinson vacutainer systems preanalyticGAS PAK II DIS. GENERATOR ENVELOPESApril 24, 1980
K800539bd becton dickinson vacutainer systems preanalyticDISP. HYDROGEN & CO2 GENERATOR ENVELOPEApril 8, 1980