510(k) Report

Devices descending from K002400

48 later devices reach Modification of Acl Advance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050661Hemosil Factor II Deficient PlasmaInstrumentation Laboratory CO20050—
+1K043459Hemosil Factor Xii Deficient PlasmaInstrumentation Laboratory CO20051—
+1K043184Hemosil RecombiplastinInstrumentation Laboratory CO200431
+1K041905Hemosil Calibration PlasmaInstrumentation Laboratory CO20044—
+1K034007Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO20042—
+1K033414Acl Top Model, TopInstrumentation Laboratory CO2004181
+1K031829Hemosil Factor IX Deficient PlasmaInstrumentation Laboratory CO20032—
+1K030965Control Plasma LMW HeparinInstrumentation Laboratory CO20037—
+1K030964Calibration Plasma LMW HeparinInstrumentation Laboratory CO20037—
+1K031122Hemosil Factor X Deficient PlasmaInstrumentation Laboratory CO20030—
+1K030287Hemosil Factor XI Deficient PlasmaInstrumentation Laboratory CO20030—
+1K024082Hemosil Factor Vii Deficient PlasmaInstrumentation Laboratory CO20030—
+1K023839Hemosil Factor V Deficient PlasmaInstrumentation Laboratory CO20030—
+1K021023Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed)Instrumentation Laboratory CO200233
+2K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company20230—
+2K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.20220—
+2K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd.20180—
+2K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory CO20180—
+2K110237Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO20111—
+2K092113Sta - Free PS CalibratorDiagnostica Stago, Inc.20090—
+2K090563Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)Instrumentation Laboratory CO20091—
+2K090209Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin ControlsInstrumentation Laboratory CO200945
+2K083159Berichrom Heparin LMW Calibrator, Berichrom Heparin LMW Control 1, and Berichrom Heparin…Siemens Healthcare Diagnostics20090—
+2K082859Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO20081—
+2K070005Hemosil Recombiplastin 2GInstrumentation Laboratory CO200721
+2K063679Acl TopInstrumentation Laboratory CO2007121
+2K060688Hemosil SynthasilInstrumentation Laboratory CO200601
+2K051472Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh CalibratorHyphen Biomed200504
+3K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.20230—
+3K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO202222
+3K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC20170—
+3K122584Hemosil Readiplas TinInstrumentation Laboratory CO201314
+3K110432Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc.20110—
+3K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc.20100—
+3K073377Acl Top (with System Software V3.0.0)Instrumentation Laboratory CO200811—
+4K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…Siemens Healthcare Diagnostics Products GmbH20240—
+4K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO20231—
+4K213426HemosIL ReadiPlasTinInstrumentation Laboratory CO20220—
+4K160276Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)Instrumentation Laboratory CO201621
+4K150877Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750…Instrumentation Laboratory CO201531
+4K091980Acl Top 700 LasInstrumentation Laboratory CO2009724
+4K083518Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer ControlsInstrumentation Laboratory CO20092—
+5K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550…Instrumentation Laboratory (IL) Co.20240—
+5K233790Acl Top 970 CLInstrumentation Laboratory20230—
+5K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO20230—
+5K231031ACL TOP Family 70 SeriesInstrumentation Laboratory Company20230—
+5K183390QNext and DG-PTDiagnostic Grifols, S.A.20190—
+5K170314ACL AcuStarInstrumentation Laboratory CO20170—