510(k) Report

Devices descending from K862301

5 later devices reach IL System 810, Acl and the Reagent Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012768Hemosil Recombi PlastinInstrumentation Laboratory CO20014—
+2K043184Hemosil RecombiplastinInstrumentation Laboratory CO200431
+3K070005Hemosil Recombiplastin 2GInstrumentation Laboratory CO200721
+4K122584Hemosil Readiplas TinInstrumentation Laboratory CO201314
+5K213426HemosIL ReadiPlasTinInstrumentation Laboratory CO20220—