ClearanceBrief
Panels › Immunology › Product code DEW · Class 2

Igg, Antigen, Antiserum, Control

Regulation 866.5510

0510(k)s in 12 months (76 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in DEW

Company510(k)sRecalls
Kent Laboratories, Inc.50
Abbott Laboratories31
Beckman Instruments, Inc.40
Dako Corp.40
Icl Scientific40
Beckman Coulter Inc03
Diagnostica, Inc.30
Helena Laboratories30
E.I. Dupont DE Nemours & Co., Inc.20
Gelco Diagnostics, Inc.20
DateFirm and productCodeLinked 510(k)
Oct 17, 2024Beckman Coulter Inc.
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative det
Open, Classified		 DEWK963868
May 16, 2018Abbott Laboratories, Inc
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, f
Terminated		 DEWK983221
Sep 30, 2010Beckman Coulter Inc.
SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920
Terminated		 DEWK965108
Jul 23, 2004Beckman Coulter Inc
IMMAGE IgM Reagent Part No.: 447610
Terminated		 DEWK963868

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