510(k) Report

Devices descending from K922273

14 later devices reach Array (R) 360 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994293Dimension C4 Flex Reagent CartridgeDade Behring, Inc.20000—
+1K994296Dimension C3 Flex Reagent CartridgeDade Behring, Inc.20000—
+1K994294Dimension TRNF Flex Reagent CartridgeDade Behring, Inc.20000—
+1K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd.20000—
+1K990552Immunoglobulin a Test SystemDade Behring, Inc.19990—
+1K990551Igg Flex Reagent CartridgeDade Behring, Inc.19996—
+1K990553Igm Flex Reagent CartridgeDade Behring, Inc.19990—
+1K962294Immage Immunochemistry SystemBeckman Instruments, Inc.199602
+2K051087Dimension Vista Integrated SystemDade Behring, Inc.2005532
+3K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics201505
+3K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.20081—
+3K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc.200613
+4K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics201502
+4K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080—