FDA.reportPublic FDA data

510(k) K853534

Device
Bbl Campy Pouch
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K853534
Product code
KZJ
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-29
Date received
1985-08-23
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#

Contact
RUSSELL ARNSBERGER
Address
Mack Centre Dr. P.O.Box 2224 Paramus NJ US 07652 07652

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
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
K841117GASPAK PLUS DISPOS. HYDROGEN &Bd Becton Dickinson Vacutainer Systems Preanalytic1984-04-04
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