FDA.reportPublic FDA data

510(k) K841117

Device
Gaspak Plus Dispos. Hydrogen &
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K841117
Product code
KZJ
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-04
Date received
1984-03-15
Regulation
866.2580
Classification name
Device, Gas Generating
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KZJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881502BREWER GEL FOR CAMPYLOBACTERFairleigh Dickinson Laboratories, Inc.1988-04-27
K875362BREWER GEL FOR ANAEROBESFairleigh Dickinson Laboratories, Inc.1988-01-27
K872782BBL(R) GASPAK CO2 POUCH(TM)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-08-06
K871709ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)Difco Laboratories, Inc.1987-05-15
K871238ANABAGScott Laboratories, Inc.1987-04-03
K862123BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICEMarion Laboratories, Inc.1986-06-16
K853534BBL CAMPY POUCHBd Becton Dickinson Vacutainer Systems Preanalytic1985-08-29
K845008BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATEMarion Laboratories, Inc.1985-03-05
K844571CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGEBd Becton Dickinson Vacutainer Systems Preanalytic1985-01-30
K832229BBL ANAGEL POWDERBd Becton Dickinson Vacutainer Systems Preanalytic1983-08-12
K820308ANA-DISC SYSTEMFlow Laboratories, Inc.1982-03-04
K820010GAS GENERATING KIT, CO2Oxoid U.S.A., Inc.1982-01-28
K811957CAMPYPAKBd Becton Dickinson Vacutainer Systems Preanalytic1981-07-23
K802494GAS GENERATING KIT SYSTEM FOR CAMPYLOB.Oxoid U.S.A., Inc.1980-11-12
K800899LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBEMiles Laboratories, Inc.1980-05-23