510(k) Report

Devices descending from K990302

7 later devices reach IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110031Hemosil Drvvt Screen & Hemosil Drvvt ConfirmInstrumentation Laboratory CO20111—
+1K061805Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmDiagnostica Stago, Inc.20061—
+1K050221Hemosil Silica Clotting TimeInstrumentation Laboratory CO20052—
+2K160445HemosIL Silica Clotting TimeInstrumentation Laboratory CO20161—
+2K113211Hemosil LA Positive Control & Hemosil LA Negative ControlInstrumentation Laboratory CO20120—
+2K083878Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LAR2 Diagnostics, Inc.20100—
+3K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.20260—