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Panels › Hematology › Product code JPA · Class 2

System, Multipurpose For In Vitro Coagulation Studies

Regulation 864.5425

1510(k)s in 12 months (181 all time)
1recalls in 12 months (44 all time)
40recalls that name a 510(k)
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Top companies in JPA

Company510(k)sRecalls
Instrumentation Laboratory1211
Bio/Data Corp.130
Dade Behring, Inc.121
Diagnostica Stago, Inc.66
International Technidyne Corp.92
Haemonetics55
Helena Laboratories81
Sigma Diagnostics, Inc.80
Siemens Healthcare Diagnostics24
Siemens Healthcare Diagnostics Products GmbH60
Decided510(k)Device and applicantCode
Apr 27, 2026K253658STA Satellite Max®
Diagnostica Stago, Inc.
JPA
Jun 2, 2025K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)
Sysmex America, Inc.
JPA
Apr 30, 2025K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Haemonetics
JPA
Jan 15, 2025K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Haemonetics Corporation
JPA
Mar 29, 2024K232018Citrated: K, KH, RTH, FFH
Haemonetics Corporation
JPA
Dec 29, 2023K233790ACL TOP 970 CL
Instrumentation Laboratory
JPA
Sep 29, 2023K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
Instrumentation Laboratory CO
JPA
Jun 7, 2023K212183STA R Max 3, STA Compact Max 3
Diagnostica Stago S.A.S, FR
JPA
Jul 8, 2022K201440ROTEM sigma Thromboelastometry System
Tem Innovations GmbH, DE
JPA
Dec 29, 2021K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activa
Accriva Diagnostics, Inc.
JPA
Nov 22, 2019K193041Hemochron Signature Elite
Accriva Diagnostics, Inc.
JPA
Aug 21, 2019K183390QNext and DG-PT
Diagnostic Grifols, S.A., ES
JPA
May 9, 2019K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
Haemonetics Corporation
JPA
May 9, 2018K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
Sekisui Medical Co., Ltd., JP
JPA
Dec 18, 2017K172286Automated Blood Coagulation Analyzer CS-2500
Siemens Healthcare Diagnostic Products GmbH, DE
JPA
Oct 31, 2017K172333Sysmex CS-5100
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
Apr 19, 2017K160502TEG 6s Hemostasis System
Haemonetics Corporation
JPA
Mar 3, 2017K170314ACL AcuStar
Instrumentation Laboratory CO
JPA
Dec 26, 2016K162688Sysmex CS-2100i
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
Dec 12, 2016K162420Sysmex Automated Blood Coagulation Analyzer CS-5100
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
Sep 2, 2016K161317Sysmex Automated Blood Coagulation Analyzer CS-5100
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
Sep 1, 2016K161312Sysmex Automated Blood Coagulation Analyzer CS-2100i
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
Jan 26, 2016K151259Sysmex Automated Blood Coagulation Analyzer CS-2100i
Siemens Healthcare Diagnostics Products GmbH, DE
JPA
Jan 11, 2016K150678Sysmex Automated Blood Coagulation Analyzer CS-5100
Siemens Healthcare Diagnostic Products GmbH, DE
JPA
Aug 7, 2015K151867STA R MAX
Diagnostica Stago S.A.S, FR
JPA
Jun 26, 2015K150041CORA (Coagulation Resonance Analysis) System
Coramed Technologies, LLC
JPA
Feb 12, 2013K130090STA COMPACT MAX
Diagnostica Stago, Incorporated, IT
JPA
Aug 10, 2011K101533EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
Tem Innovations GmbH, DE
JPA
Mar 23, 2010K083842ROTEM DELTA THROMBOELASTOMETRY SYSTEM
Pentapharm GmbH, DE
JPA
Dec 22, 2009K093167STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
Diagnostica Stago, Inc.
JPA
Dec 18, 2009K093001STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER
Diagnostica Stago, Incorporated
JPA
Jul 2, 2009K083896DESTINY MAX COAGULATION ANALYZER
Trinity Biotech
JPA
Mar 13, 2009K083518ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
Instrumentation Laboratory CO
JPA
Jan 26, 2009K083175BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
Siemens Healthcare Diagnostics
JPA
Jan 26, 2009K083159BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
Siemens Healthcare Diagnostics
JPA
Dec 12, 2008K082248STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
Diagnostica Stago, Inc.
JPA
Oct 10, 2008K082675STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
Diagnostica Stago, Inc.
JPA
Nov 30, 2007K071265SMARTCHECK INR SYSTEM
Inverness Medical Innovations, Inc.
JPA
May 10, 2006K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Helena Laboratories
JPA
Feb 21, 2006K060162ACL ELITE; ACL ELITE PRO
Instrumentation Laboratory CO
JPA
Dec 23, 2005K051030COAG-A-MATE MTX III
bioMerieux, Inc.
JPA
Jul 11, 2005K050053HEMORAM/AGGRAM ANALYZER
Helena Laboratories
JPA
Jun 6, 2005K050243IMMEDIA PROTHROMBIN TIME SYSTEM
Farallon Medial, Inc.
JPA
Apr 1, 2005K050513MDA B.30
bioMerieux, Inc.
JPA
Feb 10, 2005K050016HEMOCHRON SIGNATURE ELITE
International Technidyne Corp.
JPA
Mar 19, 2004K040359HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
Instrumentation Laboratory CO
JPA
Dec 8, 2003K033137POTENS +
Wada, Inc.
JPA
Apr 2, 2003K030818HEMOCHRON RESPONSE/SYSTEM
International Technidyne Corp.
JPA
Jan 16, 2003K023141MODIFICATION TO STANDARD HUMAN PLASMA
Dade Behring, Inc.
JPA
Aug 30, 2002K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
Sigma Diagnostics, Inc.
JPA

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