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Panels › Microbiology › Product code LSR · Class 2

Reagent, Borrelia Serological Reagent

Regulation 866.3830

2510(k)s in 12 months (112 all time)
1recalls in 12 months (5 all time)
2recalls that name a 510(k)
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Top companies in LSR

Company510(k)sRecalls
Zeus Scientific130
Gold Standard Diagnostics90
Viramed Biotech AG70
Mardx Diagnostics, Inc.60
Biomerieux S.A.23
Boston Biomedica, Inc.40
Diamedix Corp.40
DiaSorin, Inc.40
General Biometrics, Inc.40
Hillcrest Biologicals40
Decided510(k)Device and applicantCode
Sep 3, 1999K991185BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
Zeus Scientific, Inc.
LSR
Sep 3, 1999K991180BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
Zeus Scientific, Inc.
LSR
Apr 15, 1999K984234QUANTA LITE LYME IGM ELISA
Inova Diagnostics, Inc.
LSR
Apr 15, 1999K984222QUANTA LITE LYME IGG ELISA
Inova Diagnostics, Inc.
LSR
Mar 23, 1999K984138APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
Zeus Scientific, Inc.
LSR
Mar 5, 1999K980351BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
Boston Biomedica, Inc.
LSR
Feb 12, 1999K981913PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
Chembio Diagnostic Systems, Inc.
LSR
Dec 16, 1998K983606IS BORRELIA BURGDORFERI IGM TEST SYSTEM
Columbia Bioscience, Inc.
LSR
Dec 16, 1998K983605IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
Columbia Bioscience, Inc.
LSR
Jun 1, 1998K971007LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
Mrl Diagnostics
LSR
Jun 1, 1998K971006LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
Mrl Diagnostics
LSR
Apr 9, 1998K970768HUMAN LYME IGM WESTERN BLOT KIT
Cambridge Diagnostics Ireland, Ltd., IE
LSR
Apr 9, 1998K970761LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
Cambridge Diagnostics Ireland, Ltd., IE
LSR
Feb 17, 1998K971170CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
Cambridge Biotech Corp.
LSR
Feb 17, 1998K971169CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)
Cambridge Biotech Corp.
LSR
Feb 5, 1998K974810ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
Boston Biomedica, Inc.
LSR
Feb 5, 1998K974809ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
Boston Biomedica, Inc.
LSR
Mar 26, 1997K965131BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
Wampole Laboratories
LSR
Mar 26, 1997K965129BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
Wampole Laboratories
LSR
Jun 7, 1996K951709MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
Mardx Diagnostics, Inc.
LSR
Jun 5, 1996K950829MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
Mardx Diagnostics, Inc.
LSR
May 3, 1996K953683MMUNO DOT BORRELIA DOT BLOT M TEST
Genbio
LSR
May 3, 1996K953682IMMUNO DOT BORRELIA DOT BLOT G TEST
Genbio
LSR
Jun 13, 1995K943812VIDAS LYME SCREEN II
Biomerieux Vitek, Inc.
LSR
Sep 2, 1992K922578BARTELS LYME DISEASE IGM EIA
Baxter Diagnostics, Inc.
LSR
Apr 8, 1992K911627IMMUNODOT BORRELIA (LYME) TEST
General Biometrics, Inc.
LSR
Dec 30, 1991K911599IMMUNOWELL LYME (P39 RECOMBINANT) TEST
General Biometrics, Inc.
LSR
Dec 20, 1991K911590IMMUNOWELL BORRELIA (LYME)TEST
General Biometrics, Inc.
LSR
Nov 5, 1991K896378LYME-CHECK(TM) TEST KIT
Diagnostic Technology, Inc.
LSR
Oct 21, 1991K904652LYME STAT M TEST KIT
Whittaker Bioproducts, Inc.
LSR
Oct 16, 1991K904893FIAX LYME M TEST KIT
Whittaker Bioproducts, Inc.
LSR
Aug 30, 1991K910230LYME-SPOT IF KIT
Vitek Systems, Inc.
LSR
Jun 28, 1991K900206LYME DISEASE IGM ELISA
Hillcrest Biologicals
LSR
Jun 24, 1991K911496FASTTECH SYSTEM 1
3M Diagnostic Systems, Inc.
LSR
Jun 21, 1991K903013LYME IGM ELISA TEST
Gull Laboratories, Inc.
LSR
Jun 10, 1991K911330LYME IGM MICROASSAY
Diamedix Corp.
LSR
Jun 10, 1991K910899LYME DISEASE MICROASSAY
Diamedix Corp.
LSR
May 10, 1991K911145BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
Medical Diagnostic Technologies, Inc.
LSR
Dec 14, 1990K8957133M IGG FASTLYME(TM) TEST
3M Company
LSR
May 2, 1990K900572LYME IGM MICROASSAY
Diamedix Corp.
LSR
May 2, 1990K900196LYME IGM ELISA TEST SYSTEM
Zeus Scientific, Inc.
LSR
Apr 5, 1990K901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
Bion Ent., Ltd.
LSR
Dec 13, 1989K895292LYME IGG ELISA TEST SYSTEM
Zeus Scientific, Inc.
LSR
Oct 30, 1989K894410IMMUNODOT LYME TEST
General Biometrics, Inc.
LSR
Sep 19, 1989K894609MARDX LYME DISEASE IFA (IGM) TEST SYSTEM
Mardx, Inc.
LSR
Aug 21, 1989K894293MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
Mardx Diagnostics, Inc.
LSR
Aug 21, 1989K894224MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
Mardx Diagnostics, Inc.
LSR
Aug 15, 1989K892206MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
Mardx Diagnostics, Inc.
LSR
Jul 25, 1989K890843LYME DISEASE MICROASSAY
Diamedix Corp.
LSR
Apr 18, 1989K890053MARDX LYME DISEASE IGG IFA TEST SYSTEM
Mardx Diagnostics, Inc.
LSR

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