FDA.reportPublic FDA data

510(k) K020707

Device
EBV-EBNA IGG ELISA KIT, MODEL EBG-100
Applicant
Pan Bio Pty. , Ltd.
510(k) number
K020707
Product code
GNP
Decision
Substantially Equivalent (SESE)
Decision date
2002-06-13
Date received
2002-03-04
Regulation
866.3235
Classification name
Antiserum, Cf, Epstein-Barr Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
HELEN JENNINGS
Address
116 Lutwyche Rd. Windsor AU 4030 4030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GNP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K020717EBV V VCA IGM ELISA KIT MODEL# EBM-200Pan Bio Pty. , Ltd.2002-06-13
K020706EBV-VCA IGG ELISA TEST, MODEL EBG-100Pan Bio Pty. , Ltd.2002-06-13
K981831IS EBV-EA-D IGG ELISA TEST SYSTEMDiamedix Corp.1999-02-16
K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMDiamedix Corp.1999-02-16
K901156EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMGranbio, Inc.1990-09-12
K883670SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIElectro-Nucleonics, Inc.1989-04-28
K884591EBV-VCA ANTIBODY (IGG)Hillcrest Biologicals1989-01-24
K880883EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)Immuno Concepts, Inc.1988-08-30
K880885EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)Immuno Concepts, Inc.1988-08-30
K871373EBV-CHECK(TM) TEST KIT (IGG)Diagnostic Technology, Inc.1987-06-25
K861121THE GOLDEN QUAD TEST (EBV)Microbiological Research Corp.1987-02-02
K864347INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCAGranbio, Inc.1987-02-02
K863408EBV/VCA-CHECK(TM) ANTIGEN SLIDESDiagnostic Technology, Inc.1986-11-28
K854207EBV(EPSTEIN-BARR VIRUS) TEST KITImmuno-Diagnostic Products, Inc.1986-04-24
K853484INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANTBiotech Research Laboratories, Inc.1986-02-05