ClearanceBrief
Panels › Immunology › Product code DEH · Class 2

Lambda, Antigen, Antiserum, Control

Regulation 866.5550

0510(k)s in 12 months (53 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in DEH

Company510(k)sRecalls
Ventana Medical Systems, Inc.170
Dako Corp.90
The Binding Site, Ltd.70
The Binding Site Group , Ltd.14
Biotek Solutions, Inc.40
Kallestad Laboratories, Inc.40
Gelco Diagnostics, Inc.20
Icl Scientific20
Bartels Immunodiagnostic Supplies, Inc.10
Beckman Instruments, Inc.10
DateFirm and productCodeLinked 510(k)
Oct 15, 2021The Binding Site Group, Ltd.
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
Terminated		 DEHK140396
Jan 19, 2017The Binding Site Group, Ltd.
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
Terminated		 DEHK062372
Jan 19, 2017The Binding Site Group, Ltd.
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Terminated		 DEHK062372
Jan 18, 2017The Binding Site Group, Ltd.
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Terminated		 DEHK150658

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