FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K220282 |
Abbott Laboratories |
i-STAT PTplus Cartridge with the i-STAT 1 System |
07/14/2023 |
K110212 |
ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE |
INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP |
05/01/2012 |
K052124 |
AMERICAN DIAGNOSTICA, INC. |
ACTICLOT, MODEL 824 |
10/17/2005 |
K994006 |
AVOCET MEDICAL, INC. |
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) |
02/03/2000 |
K991286 |
AVOCET MEDICAL, INC. |
AVOCET ACUSURE SYSTEM |
11/18/1999 |
K092987 |
BIOSITE INCORPORATED |
INRATIO/INRATIO2 TEST STRIPS |
06/11/2010 |
K962571 |
BOEHRINGER MANNHEIM CORP. |
COAGUCHEK PST SYSTEM |
04/22/1997 |
K955843 |
CARDIOVASCULAR DIAGNOSTIC SERVICES |
TAS PTONE |
03/18/1996 |
K954625 |
CARDIOVASCULAR DIAGNOSTICS, INC. |
PROTHROMBIN TIME TEST CARD |
03/11/1996 |
K991065 |
CARESIDE, INC. |
CARESIDE PT |
07/26/1999 |
K093243 |
COAGUSENSE, INC |
COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM |
04/07/2010 |
K212779 |
CoaguSense, Inc. |
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing |
10/05/2022 |
K183255 |
CoaguSense, Inc. |
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device |
02/21/2019 |
K013155 |
DADE BEHRING, INC. |
DADE THROMBOPLASTIN C PLUS |
01/18/2002 |
K003870 |
DADE BEHRING, INC. |
THROMBOREL S |
02/20/2001 |
K974343 |
DADE INTL., INC. |
DADE INNOVIN |
07/22/1998 |
K211485 |
Diagnostica Stago SAS |
STA- NeoPTimal |
12/23/2022 |
K020679 |
HEMOSENSE, INC. |
INRATIO |
05/06/2002 |
K072727 |
HEMOSENSE, INC. |
INRATIO 2 PT MONITORING SYSTEM |
10/26/2007 |
K021923 |
HEMOSENSE, INC. |
INRATIO SELF-TEST |
10/24/2002 |
K020355 |
I-STAT CORPORATION |
I-STAT PROTHROMBIN TIME TEST |
05/14/2002 |
K201185 |
iLine Microsystems S.L. |
microINR System |
12/18/2020 |
K231711 |
iLine Microsystems S.L. |
microINR System |
07/11/2023 |
K180780 |
iLine Microsystems S.L. |
microINR System |
01/25/2019 |
K060931 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL PT-FIBRINOGEN HS PLUS |
05/02/2006 |
K122584 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL READIPLAS TIN |
03/24/2013 |
K213426 |
Instrumentation Laboratory Co. |
HemosIL ReadiPlasTin |
08/16/2022 |
K012768 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL RECOMBI PLASTIN |
09/18/2001 |
K043184 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL RECOMBIPLASTIN |
12/22/2004 |
K070005 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL RECOMBIPLASTIN 2G |
08/15/2007 |
K132722 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) |
01/22/2014 |
K981479 |
INSTRUMENTATION LABORATORY CO. |
IL TEST PT-FIBRINOGEN RECOMBINANT |
07/07/1998 |
K972866 |
INTERNATIONAL TECHNIDYNE CORP. |
HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT |
09/30/1998 |
K961835 |
INTERNATIONAL TECHNIDYNE CORP. |
PROTIME MICROCOAGULATION SYSTEM |
03/12/1997 |
K010599 |
INTERNATIONAL TECHNIDYNE CORP. |
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE |
07/02/2001 |
K022922 |
LIFESCAN, INC. |
HARMONY INR MONITORING SYSTEM |
09/30/2002 |
K001699 |
LIFESCAN, INC. |
RUBICON PROTHROMBIN TIME MONITORING SYSTEM |
05/15/2001 |
K961938 |
NOVA BIOMEDICAL CORP. |
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS |
06/28/1996 |
K974566 |
ORGANON TEKNIKA CORP. |
MDA SIMPLASTIN HTF |
02/24/1998 |
K994100 |
PACIFIC HEMOSTASIS |
PACIFIC HEMOSTASIS THROMBOPLASTIN D |
02/18/2000 |
K040296 |
R2 DIAGNOSTICS, INC. |
PHOSPHOPLASTIN RL |
05/24/2004 |
K170960 |
Roche Diagnostics |
CoaguChek Vantus System |
12/25/2017 |
K180684 |
Roche Diagnostics |
CoaguChek XS Plus System |
04/19/2018 |
K071041 |
Roche Diagnostics |
COAGUCHEK XS PLUS SYSTEM |
05/11/2007 |
K180693 |
Roche Diagnostics |
CoaguChek XS Pro System |
04/19/2018 |
K093460 |
Roche Diagnostics |
COAGUCHEK XS PRO SYSTEM |
03/18/2010 |
K060978 |
Roche Diagnostics |
COAGUCHEK XS SYSTEM |
08/11/2006 |
K030845 |
ROCHE DIAGNOSTICS CORP. |
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING |
05/22/2003 |
K092940 |
ROCHE DIAGNOSTICS CORP. |
COAGUCHEK XS PLUS PST SYSTEM |
03/05/2010 |
K062925 |
ROCHE DIAGNOSTICS CORP. |
COAGUCHEK XS SYSTEM |
01/29/2007 |
K072920 |
ROCHE DIAGNOSTICS CORP. |
HANDHELD BASE UNIT |
01/31/2008 |
K020831 |
ROCHE DIAGNOSTICS CORP. |
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 |
10/24/2002 |
K021190 |
ROCHE DIAGNOSTICS CORP. |
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 |
10/25/2002 |
K992492 |
ROCHE DIAGNOSTICS CORP. |
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM |
11/02/1999 |
K151964 |
SIEMENS HEALTHCARE DIAGNOSTICS |
Xprecia Stride Coagulation System, Xprecia System PT Controls |
09/30/2016 |
K972796 |
SIGMA DIAGNOSTICS, INC. |
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM |
10/10/1997 |
K020840 |
VITAL SCIENTIFIC N.V. |
VITAL SCIENTIFIC PT WITH CALCIUM |
05/15/2002 |