FDA.reportPublic FDA data

510(k) K030863

Device
EBV VCA-P18 IGG ELISA
Applicant
Panbio Limited
510(k) number
K030863
Product code
LSE
Decision
Substantially Equivalent (SESE)
Decision date
2003-06-27
Date received
2003-03-18
Regulation
866.3235
Classification name
Epstein-Barr Virus, Other
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

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510(k), Device, Applicant table
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K062211BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, Inc.2006-12-08
K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, Inc.2006-12-08
K060204LIAISON EA IGGDiaSorin, Inc.2006-10-18
K033915MODIFICATION TO SERAQUEST EB VCA IGGQuest Intl., Inc.2004-01-16
K021793EBV EA-D IGG ELISA KIT, MODEL EBG-100Pan Bio Pty. , Ltd.2002-09-27
K010301IMMUNOWELL EA (D) IGG TESTGenbio2001-06-11
K992587EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEMStellar Bio Systems, Inc.1999-12-22
K991975SERAQUEST EB NA IGGQuest Intl., Inc.1999-11-02
K990410SERAQUEST EB VCA IGGQuest Intl., Inc.1999-10-28
K992191ETI-EA-G ASSAYDiaSorin, Inc.1999-07-12