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Panels › Immunology › Product code LTK · Class 2

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

Regulation 866.6010

0510(k)s in 12 months (26 all time)
0recalls in 12 months (13 all time)
11recalls that name a 510(k)
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Top companies in LTK

Company510(k)sRecalls
Siemens Healthcare Diagnostics24
Abbott Laboratories HPD/ADD/GPRD05
Bayer Corp.30
Beckman Coulter, Inc.30
Ortho Clinical Diagnostics21
Abbott Laboratories11
BioCheck Inc02
bioMerieux, Inc.20
Boehringer Mannheim Corp.20
Diagnostic Products Corp.20
DateFirm and productCodeLinked 510(k)
May 4, 2018Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125)
Terminated		 LTKK983391
May 4, 2018Siemens Healthcare Diagnostics, Inc.
IMMULITE /IMMULITE 1000 OM-MA (CA125)
Terminated		 LTKK981297
Feb 21, 2018Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Terminated		 LTKK020828
Dec 17, 2013Ortho-Clinical Diagnostics
VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative mea
Terminated		 LTKK983875
Mar 11, 2011BioCheck Inc
CA15-3 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Terminated		 LTKNone listed
Mar 11, 2011BioCheck Inc
CA125 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Terminated		 LTKNone listed
Mar 2, 2011Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows: Product code: 09427226 (128532) 100 test kit Product code: 01678114 (128533) 500 Test kit
Terminated		 LTKK020828
Jul 11, 2007Abbott Laboratories
AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Terminated		 LTKK964020
Jan 10, 2004Abbott Laboratories HPD/ADD/GPRD
CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064
Terminated		 LTKK964185
K964929
Jan 10, 2004Abbott Laboratories HPD/ADD/GPRD
AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064
Terminated		 LTKK964020
Jan 10, 2004Abbott Laboratories HPD/ADD/GPRD
CA 125 Calibrators, list 9C22-01; Abbott Laboratories, Abbott Park, IL 60064
Terminated		 LTKK964020
K964185
Jan 10, 2004Abbott Laboratories HPD/ADD/GPRD
IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064
Terminated		 LTKK964185
Jan 10, 2004Abbott Laboratories HPD/ADD/GPRD
AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Abbott Laboratories, Abbott Park, IL 60064
Terminated		 LTKK964020
K964185

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