510(k) Report

Devices descending from K972075

13 later devices reach Vacutainer Brand PPT Plasma Preparation Tube through their predicates, nearest generation first.

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