ClearanceBrief
Panels › Immunology › Product code DHX · Class 2

System, Test, Carcinoembryonic Antigen

Regulation 866.6010

0510(k)s in 12 months (28 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
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Top companies in DHX

Company510(k)sRecalls
Beckman Coulter, Inc.32
Ortho Clinical Diagnostics31
Diagnostic Products Corp.12
Siemens Healthcare Diagnostics, Inc.02
Tosoh Medics, Inc.20
Abbott Laboratories10
Amicon, Inc.10
Bayer Corp.10
Bd Becton Dickinson Vacutainer Systems Preanalytic10
Beckman10
DateFirm and productCodeLinked 510(k)
May 4, 2018Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000/IMMULITE 2000 XPi CEA
Terminated		 DHXK980855
May 4, 2018Siemens Healthcare Diagnostics, Inc.
IMMULITE /IMMULITE 1000 CEA
Terminated		 DHXK970877
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
Terminated		 DHXK023893
Nov 6, 2015Beckman Coulter Inc.
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Terminated		 DHXK031270
Mar 11, 2011BioCheck Inc
CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Terminated		 DHXNone listed
Aug 1, 2006Beckman Coulter Inc
Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200
Terminated		 DHXK981985
Jul 16, 2005Diagnostic Products Corp
Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
Terminated		 DHXK970877
Jul 20, 2004Diagnostic Products Corp
Immulite 1000 CEA Catalog No. LKCE1
Terminated		 DHXK970877
Jan 6, 2004Ortho-Clinical Diagnostics
Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
Terminated		 DHXNone listed

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