System, Multipurpose For In Vitro Coagulation Studies

JPA 2025-06-02

Automated Blood Coagulation Analyzer CN-Series (CN-6000)

Applicant Sysmex America, Inc.

K number K250965

JPA 2025-04-30

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

Applicant Haemonetics

K number K251024

JPA 2025-01-15

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

Applicant Haemonetics Corporation

K number K243858

JPA 2024-03-29

Citrated: K, KH, RTH, FFH

Applicant Haemonetics Corporation

K number K232018

JPA 2023-12-29

ACL TOP 970 CL

Applicant Instrumentation Laboratory

K number K233790

JPA 2023-09-29

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM

K number K221359

JPA 2023-06-07

STA R Max 3, STA Compact Max 3

Applicant Diagnostica Stago S.A.S

K number K212183

JPA 2022-07-08

ROTEM sigma Thromboelastometry System

Applicant Tem Innovations GmbH

K number K201440

JPA 2021-12-29

GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2

Applicant Accriva Diagnostics, Inc.

K number K202101

JPA 2019-11-22

Hemochron Signature Elite

Applicant Accriva Diagnostics, Inc.

K number K193041

JPA 2019-08-21

QNext and DG-PT

Applicant Diagnostic Grifols, S.A.

K number K183390

JPA 2019-05-09

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge

Applicant Haemonetics Corporation

K number K183160

JPA 2018-05-09

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set

Applicant Sekisui Medical Co., Ltd.

K number K173202

JPA 2017-12-18

Automated Blood Coagulation Analyzer CS-2500

Applicant Siemens Healthcare Diagnostic Products GmbH

K number K172286

JPA 2017-10-31

Sysmex CS-5100

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K172333

JPA 2017-04-19

TEG 6s Hemostasis System

Applicant Haemonetics Corporation

K number K160502

JPA 2017-03-03

ACL AcuStar

K number K170314

JPA 2016-12-26

Sysmex CS-2100i

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K162688

JPA 2016-12-12

Sysmex Automated Blood Coagulation Analyzer CS-5100

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K162420

JPA 2016-09-02

Sysmex Automated Blood Coagulation Analyzer CS-5100

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K161317

JPA 2016-09-01

Sysmex Automated Blood Coagulation Analyzer CS-2100i

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K161312

JPA 2016-01-26

Sysmex Automated Blood Coagulation Analyzer CS-2100i

Applicant Siemens Healthcare Diagnostics Products GmbH

K number K151259

JPA 2016-01-11

Sysmex Automated Blood Coagulation Analyzer CS-5100

Applicant Siemens Healthcare Diagnostic Products GmbH

K number K150678

JPA 2013-02-12

STA COMPACT MAX

Applicant Diagnostica Stago, Incorporated

K number K130090

JPA 2011-08-10

EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM

Applicant Tem Innovations GmbH

K number K101533

JPA 2010-03-23

ROTEM DELTA THROMBOELASTOMETRY SYSTEM

Applicant Pentapharm GmbH

K number K083842

JPA 2009-12-22

STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER

Applicant Diagnostica Stago, Inc.

K number K093167

JPA 2009-12-18

STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER

Applicant Diagnostica Stago, Incorporated

K number K093001

JPA 2009-07-02

DESTINY MAX COAGULATION ANALYZER

Applicant Trinity Biotech

K number K083896

JPA 2009-03-13

ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS

K number K083518

JPA 2009-01-26

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

Applicant Siemens Healthcare Diagnostics

K number K083175

JPA 2009-01-26

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

Applicant Siemens Healthcare Diagnostics

K number K083159

JPA 2008-12-12

STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER

Applicant Diagnostica Stago, Inc.

K number K082248

JPA 2008-10-10

STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER

Applicant Diagnostica Stago, Inc.

K number K082675

JPA 2007-11-30

SMARTCHECK INR SYSTEM

Applicant Inverness Medical Innovations, Inc.

K number K071265

JPA 2006-05-10

ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP

Applicant Helena Laboratories

K number K061014

JPA 2006-02-21

ACL ELITE; ACL ELITE PRO

K number K060162

JPA 2005-12-23

COAG-A-MATE MTX III

Applicant bioMerieux, Inc.

K number K051030

JPA 2005-07-11

HEMORAM/AGGRAM ANALYZER

Applicant Helena Laboratories

K number K050053

JPA 2005-06-06

IMMEDIA PROTHROMBIN TIME SYSTEM

Applicant Farallon Medial, Inc.

K number K050243

JPA 2005-04-01

MDA B.30

Applicant bioMerieux, Inc.

K number K050513

JPA 2005-02-10

HEMOCHRON SIGNATURE ELITE

K number K050016

JPA 2004-03-19

HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2

K number K040359

JPA 2003-12-08

POTENS +

Applicant Wada, Inc.

K number K033137

JPA 2003-04-02

HEMOCHRON RESPONSE/SYSTEM

K number K030818

JPA 2003-01-16

MODIFICATION TO STANDARD HUMAN PLASMA

Applicant Dade Behring, Inc.

K number K023141

JPA 2002-08-30

AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED

Applicant Sigma Diagnostics, Inc.

K number K021162

JPA 2002-03-28

HEMOCHRON JR. SIGNATURE +

K number K020798

JPA 2001-11-09

BCS SYSTEM

Applicant Dade Behring, Inc.

K number K013114

JPA 2001-08-09

BCT SYSTEM

Applicant Dade Behring, Inc.

K number K011665

JPA 2001-07-20

SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500

Applicant Dade Behring, Inc.

K number K011235

JPA 2001-05-01

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

Applicant Dade Behring, Inc.

K number K010494

JPA 2000-11-16

BEHRING COAGULATION SYSTEM, MODEL BCS

Applicant Dade Behring, Inc.

K number K002080

JPA 2000-09-14

THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES

Applicant Haemoscope Corp.

K number K002177

JPA 2000-09-06

COAGUCHEK S SYSTEM, MODEL 2138280

Applicant Roche Diagnostics Corp.

K number K994349

JPA 2000-08-30

MODIFICATION OF ACL ADVANCE

K number K002400

JPA 2000-06-21

BEHRING COAGULATION TIMER ANALYZER (BCT)

Applicant Dade Behring, Inc.

K number K001064

JPA 2000-06-20

DADE BEHRING COAGULATION ANALYZER (BCT)

Applicant Dade Behring, Inc.

K number K001067

JPA 2000-05-26

BEHRING COAGULATION SYSTEM (BCS)

Applicant Dade Behring, Inc.

K number K000973

JPA 2000-05-05

THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES

Applicant Haemoscope Corp.

K number K993678

JPA 2000-03-15

ACL 9000 SYSTEM

K number K000053

JPA 2000-01-11

BEHRING COAGULATION SYSTEM (BCS)

Applicant Dade Behring, Inc.

K number K992959

JPA 1999-07-28

DADE BEHRING BFTII

Applicant Dade Behring, Inc.

K number K984501

JPA 1999-05-14

TAS ANALYZER, MODEL 1009

Applicant Cardiovascular Diagnostics, Inc.

K number K990566

JPA 1999-04-13

HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE

K number K990449

JPA 1999-04-13

COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P

Applicant Roche Diagnostics/Boehringer Mannheim GmbH

K number K983892

JPA 1998-11-12

STAR AUTOMATED MULTI-PARAMETRIC ANALYZER

Applicant American Bioproducts Co.

K number K983460

JPA 1998-09-30

SYSMEX AUTOMATED COAGULATION ANALYZER CA-500

Applicant Dade Behring, Inc.

K number K981711

JPA 1998-09-30

AVOCET PT

Applicant Avocet Medical, Inc.

K number K980839

JPA 1998-07-30

HEPTRAC ELECTRONIC QUALITY CONTROL

Applicant Medtronic Blood Management

K number K981815

JPA 1998-07-07

HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE

K number K974799

JPA 1998-01-09

COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING

Applicant Boehringer Mannheim Corp.

K number K974569

JPA 1997-10-20

CS-400 COAGULATION ANALYZER SYSTEM (A1208)

Applicant Sigma Diagnostics, Inc.

K number K972260

JPA 1997-05-05

BEHRING COAGULATION SYSTEM

Applicant Behring Diagnostics, Inc.

K number K970431

JPA 1997-03-18

SYSMEX CA-1000/SYSMEX CA-5000

Applicant Sysmex Corp.

K number K964946

JPA 1996-12-10

THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451

Applicant Helena Laboratories

K number K961908

JPA 1996-09-10

KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)

Applicant Sigma Diagnostics, Inc.

K number K960875

JPA 1996-06-20

PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS

Applicant Medtronic Hemotec, Inc.

K number K954202

JPA 1996-03-13

AMAX CS-190 COAGULATION ANALYZER SYSTEM

Applicant Sigma Diagnostics, Inc.

K number K955720

JPA 1996-03-12

KC 1A COAGULATION ANALYZER/SET

Applicant Sigma Diagnostics, Inc.

K number K955724

JPA 1996-03-11

KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM

Applicant Sigma Diagnostics, Inc.

K number K955735

JPA 1995-11-21

COAGUCHEK SYSTEM

Applicant Boehringer Mannheim Corp.

K number K952625

JPA 1995-11-03

ACL FUTURA COAGULATION SYSTEM

K number K951891

JPA 1995-09-05

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER

Applicant Sienco, Inc.

K number K952560

JPA 1995-09-01

CASCASE 480 SNSLYZER

Applicant Helena Laboratories

K number K951497

JPA 1995-04-18

BEHRING FIBRINTIMER A

Applicant Behring Diagnostics, Inc.

K number K926551

JPA 1995-03-24

TOA MEDICAL ELECTRONICS CA-5000

Applicant Sysmex Corp.

K number K942097

JPA 1995-03-24

TOA MEDICAL ELECTRONICS CA-1000

Applicant Sysmex Corp.

K number K942096

JPA 1994-10-18

HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM

K number K940957

JPA 1994-07-19

ACT CONTROL SET

Applicant Sigma Diagnostics, Inc.

K number K940840

JPA 1994-05-11

JR. MICROCOAGULATION SYSTEM

K number K940401

JPA 1994-01-27

TOA MEDICAL ELECTRONICS CA-5000

Applicant Toa Medical Electronics USA, Inc.

K number K933886

JPA 1993-12-03

R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470

Applicant R & D Batteries, Inc.

K number K934747

JPA 1993-11-03

CA-1000 AUTOMATED COAGULATION ANALYZER

Applicant Toa Medical Electronics USA, Inc.

K number K931149

JPA 1993-09-22

DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI

Applicant Baxter Diagnostics, Inc.

K number K933188

JPA 1993-09-02

HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION

Applicant Technidyne Corp.

K number K930068

JPA 1993-08-05

BOEHRINGER MANNHEIM COAGUCHEK SYSTEM

Applicant Boehringer Mannheim Corp.

K number K930454

JPA 1993-04-20

VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA

Applicant Organon Teknika Corp.

K number K930849

JPA 1993-03-23

COAGULATION CONTROL CONTAINING HEMOGLOBIN

Applicant Analytical Control Systems, Inc.

K number K925340