ClearanceBrief
Panels › Microbiology › Product code LFZ · Class 2

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Regulation 866.3175

0510(k)s in 12 months (58 all time)
1recalls in 12 months (9 all time)
7recalls that name a 510(k)
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Top companies in LFZ

Company510(k)sRecalls
Abbott Laboratories62
Zeus Scientific, Inc.51
Behring Diagnostics, Inc.50
Gull Laboratories, Inc.40
Roche Diagnostics40
DiaSorin, Inc.30
Incstar Corp.30
Mercia Diagnostics , Ltd.30
BioMerieux SA02
Diagnostic Products Corp.20
Decided510(k)Device and applicantCode
Mar 27, 1989K883399UBI MAGIWEL CMV IGG QUANTITATIVE
United Biotech, Inc.
LFZ
Mar 27, 1989K880433CYTOMEGALOVIRUS IGG EIA KIT
De Ferris Laboratories, Inc.
LFZ
May 13, 1988K875361SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
Disease Detection International, Inc.
LFZ
Sep 16, 1985K852478ENZYGNOST + ANTI-CMV IGG TEST
Behring Diagnostics, Inc.
LFZ
Oct 27, 1983K832221YBBOTT CMV TOTAL AB EIA
Abbott Laboratories
LFZ
Aug 8, 1983K831343CMV RQ BIO-ENZABEAD KIT
Litton Bionetics
LFZ
May 9, 1983K830615CYTOMEGELISA STAT
M.A. Bioproducts
LFZ
Dec 28, 1982K823123CORDIA CMV
Cordis Corp.
LFZ

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