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Panels › Microbiology › Product code LGD · Class 2

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Regulation 866.3780

0510(k)s in 12 months (106 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
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Top companies in LGD

Company510(k)sRecalls
Abbott Laboratories122
Beckman Coulter, Inc.70
Gull Laboratories, Inc.60
Labsystems, Inc.50
bioMerieux, Inc.22
Diamedix Corp.40
Zeus Scientific, Inc.40
Bayer Corp.30
Bio-Rad Laboratories21
Biomerieux Vitek, Inc.30
Decided510(k)Device and applicantCode
Jan 4, 1985K843417CORDIA T-M
Cordis Corp.
LGD
Oct 17, 1984K842797TOXOPLASMA GONDII IGM EIA TEST KIT
Labsystems, Inc.
LGD
Sep 7, 1984K842528AMIZYME-TOXOPLASMA GONDII KIT
Amico Lab, Inc.
LGD
May 21, 1984K840879TOXO-G EIA DIAGNOSTIC KIT
Abbott Laboratories
LGD
Apr 24, 1984K833829TOXOPLASMA GOND II IGG DIA TEST KIT
Labsystems, Inc.
LGD
Jan 26, 1982K813221TOXOELISA TEST KIT
M.A. Bioproducts
LGD

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