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LTK — Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Class II

FDA Device Classification

Classification Details

Product Code
LTK
Device Class
Class II
Regulation Number
866.6010
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240479beckman coulterAccess OV MonitorMay 10, 2024
K213510siemens healthcare diagnostics productsIMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MASeptember 8, 2023
K221355ortho clinical diagnosticsVITROS Immuodiagnostic Products CA 125 II Reagent PackDecember 12, 2022
K200199siemens healthcare diagnosticsADVIA Centaur CA 125IIApril 6, 2020
K143534roche professional diagnosticsElecsys CA-125 II assayAugust 6, 2015
K142895fujirebio diagnosticsLUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSMay 21, 2015
K100321siemens healthcare diagnosticsDIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CApril 12, 2011
K080469biomerieuxVIDAS CA 15-3 ASSAYJune 22, 2009
K080561biomerieuxVIDAS CA 125 II ASSAYApril 10, 2009
K072794siemens medical solutions diagnosticsIMMULITE 2500 OM-MA, MODEL L5KOPNovember 5, 2007
K042731fujirebio diagnosticsARCHITECT CA 125 II ASSAYNovember 19, 2004
K031297beckman coulterACCESS OV MONITOR ASSAYMay 2, 2003
K023597beckman coulterACCESS OV MONITOR IMMUNOENZYMETRIC ASSAYDecember 11, 2002
K023891tosoh medicsST AIA-PACK CA 125 ENZYME IMMUNOASSAYDecember 6, 2002
K022329bayer diagnosticsCA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMNovember 27, 2002
K020828bayerCA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEMJuly 24, 2002
K990431tosoh medicsAIA-PACK CA 125June 3, 1999
K983875ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC May 14, 1999
K983715bayerTHE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC May 14, 1999
K983391diagnostic productsIMMULITE 2000 OM-MA MODEL L2KOP2October 15, 1998