ClearanceBrief
Panels › Microbiology › Product code LSE · Class 1

Epstein-Barr Virus, Other

Regulation 866.3235

2510(k)s in 12 months (58 all time)
1recalls in 12 months (7 all time)
5recalls that name a 510(k)
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Top companies in LSE

Company510(k)sRecalls
DiaSorin, Inc.51
Bio-Rad Laboratories, Inc.23
Zeus Scientific, Inc.50
Genbio40
Quest Intl., Inc.40
Whittaker Bioproducts, Inc.40
Biotest Diagnostics Corp.30
Clark Laboratories, Inc.30
Columbia Bioscience, Inc.30
Gull Laboratories, Inc.30
Decided510(k)Device and applicantCode
Aug 30, 1989K894235EB VCA STAT M TEST KIT
Whittaker Bioproducts, Inc.
LSE
Jul 14, 1989K883871EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
Clinical Sciences, Inc.
LSE
Jul 14, 1989K883870EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
Clinical Sciences, Inc.
LSE
May 10, 1989K891086STAT TEST KIT FOR EB-VCA IGG ANTIBODY
Whittaker Bioproducts, Inc.
LSE
Dec 15, 1988K882447EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES
Zeus Scientific, Inc.
LSE
Aug 3, 1988K882023FIAX TEST KIT FOR EB-VCA-G ANTIBODY
Whittaker Bioproducts, Inc.
LSE
Jun 7, 1988K881617INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY
Granbio, Inc.
LSE
Jan 5, 1988K872617EBV-EA TEST
Gull Laboratories, Inc.
LSE

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