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
Decided510(k)Device and applicantCode
Nov 17, 1982K822670ANTISERUM TO HUMAN IGM
Amico Lab, Inc.
DFH
Nov 17, 1982K822669ANTISERUM TO HUMAN IGG
Amico Lab, Inc.
DFH
Nov 17, 1982K822668ANTISERUM TO HUMAN IGA
Amico Lab, Inc.
DFH
Nov 17, 1982K822667ANTISERUM TO HUMAN LAMBDA
Amico Lab, Inc.
DFH
Nov 17, 1982K822666ANTISERUM TO HUMAN KAPPA
Amico Lab, Inc.
DFH
Feb 10, 1982K812485DAKO PAP KIT K504
Dako Corp.
DFH
Sep 29, 1981K812661IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA
Dako Corp.
DFH
Jul 16, 1981K811721H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME
Immulok, Inc.
DFH
Oct 23, 1980K802283ANTISERA TO HUMAN FREE KAPPA CHAINS
Kallestad Laboratories, Inc.
DFH
Nov 27, 1979K791284ANTI-HUMAN KAPPA SERUM
Diagnostica, Inc.
DFH
Sep 12, 1979K790706ANTISERUM TO RABBIT IGG H & L CHAIN
Kent Laboratories, Inc.
DFH
Jul 27, 1978K781028KAPPA SERUM (FREE & BOUND) ANTI-HUMAN
Icl Scientific
DFH
Jul 27, 1978K781027KAPPA SERUM (FREE) ANTI-HUMAN
Icl Scientific
DFH

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