510(k) Report

Devices descending from K020566

10 later devices reach Fujirebio Diagnostics CA 19-9 Ria through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052889Vitros CA 19-9Fujirebio Diagnostics,Inc.20051—
+1K052000Architect CA 19-9XR AssayFujirebio Diagnostics,Inc.200521
+1K050231Elecsys CA 19-9 Immunoassay, Elecsys CA 19-9 CalsetRoche Diagnostics Corp.200501
+1K033038GI Monitor and GI Monitor Calibrators on the Access Immunoassay Systems, Model 387687…Beckman Coulter, Inc.200302
+1K031393Bayer Advia Centaur CA 19-9 AssayBayer Healthcare, LLC200328
+2K253528Atellica IM CA 19-9 IISiemens Healthcare Diagnostics, Inc.20260—
+2K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackOrtho Clinical Diagnostics20230—
+2K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.20191—
+2K100375Dimension Vista Loci CA 19-9 Flex Reagent Cartridge, and Dimension LOCI7 Calibrator with…Siemens Healthcare Diagnostics, Inc.20110—
+3K200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc.20200—