510(k) Report

Devices descending from K033414

18 later devices reach Acl Top Model, Top through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063679Acl TopInstrumentation Laboratory CO2007121
+1K060688Hemosil SynthasilInstrumentation Laboratory CO200601
+1K043184Hemosil RecombiplastinInstrumentation Laboratory CO200431
+2K073377Acl Top (with System Software V3.0.0)Instrumentation Laboratory CO200811—
+2K070005Hemosil Recombiplastin 2GInstrumentation Laboratory CO200721
+3K160276Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)Instrumentation Laboratory CO201621
+3K150877Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750…Instrumentation Laboratory CO201531
+3K122584Hemosil Readiplas TinInstrumentation Laboratory CO201314
+3K091980Acl Top 700 LasInstrumentation Laboratory CO2009724
+3K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO20092—
+4K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550…Instrumentation Laboratory (IL) Co.20240—
+4K233790Acl Top 970 CLInstrumentation Laboratory20230—
+4K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO20230—
+4K231031ACL TOP Family 70 SeriesInstrumentation Laboratory Company20230—
+4K213426HemosIL ReadiPlasTinInstrumentation Laboratory CO20220—
+4K183390QNext and DG-PTDiagnostic Grifols, S.A.20190—
+4K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd.20180—
+4K170314ACL AcuStarInstrumentation Laboratory CO20170—