ClearanceBrief
Panels › Immunology › Product code DFH · Class 2

Kappa, Antigen, Antiserum, Control

Regulation 866.5550

1510(k)s in 12 months (63 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in DFH

Company510(k)sRecalls
Amico Lab, Inc.140
The Binding Site, Ltd.80
The Binding Site Group , Ltd.42
Siemens Healthcare Diagnostics Products GmbH60
Diazyme Laboratories50
Beckman Instruments, Inc.40
Sebia30
Biotek Solutions, Inc.20
Dako Corp.20
Gelco Diagnostics, Inc.20
DateFirm and productCodeLinked 510(k)
May 20, 2021The Binding Site Group, Ltd.
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096
Terminated		 DFHK070900
Nov 18, 2020The Binding Site Group, Ltd.
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Terminated		 DFHK173732

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