510(k) Report

Devices descending from K953463

14 later devices reach Vacutainer Plus Tubes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972075Vacutainer Brand PPT Plasma Preparation TubeBecton Dickinson Vacutainer Systems199813—
+2K142821PAXgene Blood DNA TubePreanalytix GmbH20151—
+2K110701Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500DNA Genotek, Inc.20116—
+2K042927Vacuette Edta K3 Evacuated Blood Collection TubesGreiner Bio-One Vacuette North America20050—
+2K014104Vacuette Edta K2 TubesGreiner Vacuette North America, Inc.20021—
+2K012043Vacuette Edta K2 Gel TubesGreiner Vacuette North America, Inc.20010—
+3K231469PAXgene® Blood DNA TubePreanalytix GmbH20230—
+3K192920Oragene®•DxDNA Genotek, Inc.20201—
+3K152464ORAcollect.DxDNA Genotek, Inc.201601
+3K152556Oragene DxDNA Genotek, Inc.20162—
+3K141410Oragene DX Ogd-500.001DNA Genotek, Inc.20153—
+3K063357Minicollect Capillary Blood Collection TubesGreiner Bio-One North America, Inc.20070—
+4K212745ORAcollect®•DxDNA Genotek, Inc.20220—
+4K192947AncestryDNA Saliva Collection KitAncestry Genomics, Inc.20200—