ClearanceBrief
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
Apr 10, 1989K885294BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
Medical Diagnostic Technologies, Inc.
LSR
Apr 10, 1989K885293BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
Medical Diagnostic Technologies, Inc.
LSR
Apr 10, 1989K885290BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY
Medical Diagnostic Technologies, Inc.
LSR
Mar 15, 1989K890281HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES
Cambridge Bioscience Corp.
LSR
Mar 15, 1989K883767LYME DISEASE IFA (IGM)
Hillcrest Biologicals
LSR
Mar 2, 1989K885317LYME ELISA TEST SYSTEM
Zeus Scientific, Inc.
LSR
Jan 13, 1989K883544LYME FAST TEST
3M Company
LSR
Dec 13, 1988K883487LYME DISEASE IFA (IGG)
Hillcrest Biologicals
LSR
Apr 26, 1988K880476LYME DISEASE ELISA
Hillcrest Biologicals
LSR
Mar 30, 1988K875286LYME STAT TEST KIT
Whittaker Bioproducts, Inc.
LSR
Oct 15, 1987K872247FIAX TEST KIT FOR LYME DISEASE ANTIBODIES
Whittaker Bioproducts, Inc.
LSR
Aug 25, 1987K871246IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI
Zeus Scientific, Inc.
LSR

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