ClearanceBrief
Panels › Immunology › Product code DFT · Class 2

Igm, Antigen, Antiserum, Control

Regulation 866.5550

0510(k)s in 12 months (33 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in DFT

DateFirm and productCodeLinked 510(k)
Dec 3, 2022Randox Laboratories Ltd.
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Terminated
DFTK955797
May 16, 2018Abbott Laboratories, Inc
Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, f
Terminated
DFTK983132
Jan 11, 2006Abbott Laboratories Diagnostic Div
Clinical Chemistry Immunoglobulin M, List Number 1E01-20
Terminated
DFTK983132
Jul 20, 2004Abbott Laboratories Diagnostic Div
AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA
Terminated
DFTK982132

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