510(k) Report

Devices descending from K053072

8 later devices reach N Antisera to Human ALPHA1-Antitrypsin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…Dade Behring, Inc.20076—
+1K063610Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium…Dade Behring, Inc.20070—
+2K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc.20074—
+2K071980Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,HDade Behring, Inc.20072—
+3K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics200912
+3K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.20081—
+4K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH20230—
+4K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080—