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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
DateFirm and productCodeLinked 510(k)
Oct 30, 2026Accriva Diagnostics, Inc.
Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
Open, Classified		 JPAK940401
Aug 28, 2025Diagnostica Stago, Inc.
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologi
Open, Classified		 JPAK082248
May 10, 2023Diagnostica Stago, Inc.
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
Open, Classified		 JPAK130090
May 10, 2023Diagnostica Stago, Inc.
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Open, Classified		 JPAK093167
May 10, 2023Diagnostica Stago, Inc.
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Open, Classified		 JPAK151867
Apr 26, 2022Haemonetics Corporation
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Terminated		 JPAK002177
Apr 19, 2022Haemonetics Corporation
Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), Platelet
Terminated		 JPAK002177
K041502
Mar 2, 2021Siemens Healthcare Diagnostics, Inc.
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform qua
Terminated		 JPAK970431
Nov 9, 2020Helena Laboratories, Corp.
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Open, Classified		 JPAK013078
K061014
Feb 19, 2020Haemonetics Corporation
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
Terminated		 JPAK002177
Jul 23, 2019Instrumentation Laboratory Co.
ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
Terminated		 JPAK101533
Jul 23, 2019Instrumentation Laboratory Co.
ROTEM ex-tem Canada Part No: 503-05-CA
Terminated		 JPAK101533
Jul 23, 2019Instrumentation Laboratory Co.
ROTEM ex-tem; US Part No: 503-05-US
Terminated		 JPAK101533
Sep 13, 2016TEM Systems Inc
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM
Terminated		 JPAK101533
Apr 22, 2016Accriva Diagnostics Inc., dba ITC, dba Accumetrics
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Terminated		 JPAK940401
Feb 19, 2016Siemens Healthcare Diagnostics, Inc.
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 104618
Terminated		 JPAK970431
Feb 19, 2016Siemens Healthcare Diagnostics, Inc.
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING CO
Terminated		 JPAK013114
Apr 3, 2015TEM Systems Inc
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Terminated		 JPAK083842
K101533
Feb 19, 2015Haemonetics Corporation
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
Terminated		 JPAK002177
Jul 21, 2014ITC-Nexus Dx
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Terminated		 JPAK940401
Jul 24, 2013Haemonetics Corporation
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Terminated		 JPAK002177
Nov 6, 2012Diagnostica Stago, Inc.
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in
Terminated		 JPAK082248
Jun 26, 2012Siemens Healthcare Diagnostics, Inc.
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
Terminated		 JPAK013114
Aug 5, 2011International Technidyne Corp.
Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx. A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
Terminated		 JPAK940432
K974799
Aug 5, 2011International Technidyne Corp.
IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
Terminated		 JPAK940432
K974799
Jul 6, 2011Haemoscope Division of Haemonetics Corp
TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification f
Terminated		 JPAK002177
Mar 21, 2011Haemoscope Division of Haemonetics Corp
TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose syst
Terminated		 JPAK002177
Dec 27, 2010Instrumentation Laboratory Co.
ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing.
Terminated		 JPAK060162
Dec 27, 2010Instrumentation Laboratory Co.
ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing.
Terminated		 JPAK060162
Dec 27, 2010Instrumentation Laboratory Co.
ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing.
Terminated		 JPAK060162
Dec 27, 2010Instrumentation Laboratory Co.
ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing.
Terminated		 JPAK060162
Dec 27, 2010Instrumentation Laboratory Co.
ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing.
Terminated		 JPAK060162
May 4, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. A microprocessor based, multichannel clot timing instrument with automated syringe h
Terminated		 JPANone listed
Feb 7, 2008Inotech Biosystems Intl., Inc
Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing 70mg of Heparin Adsorbent, 10 tubes per foil lined pouch, 10 foil pouches/box, Inotech Biosystems I
Terminated		 JPAK870771
Oct 22, 2005BIOMERIEUX, INC.
VeriCal Calibrator Set
Terminated		 JPANone listed
Aug 30, 2005Diagnostica Stago, Inc.
STA-R blood coagulation analyzer. Catalog Number 57160.
Terminated		 JPANone listed
Jun 21, 2005Instrumentation Laboratory Co.
ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
Terminated		 JPAK002400
K033414 +1
Oct 23, 2004bioMerieux
The MDA system with MDA Antithrombin III MDA Heparin
Terminated		 JPANone listed
Oct 23, 2004Dade Behring , Inc.
DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Terminated		 JPAK011665
Jul 20, 2004Instrumentation Laboratory Co.
ACL Advance Instrument Analyzer
Terminated		 JPAK002400
Jul 20, 2004Instrumentation Laboratory Co.
ACL Futura Instrument Analyzer
Terminated		 JPAK951891
May 14, 2003Roche Diagnostics Corp.
CoaguChek Plus meter; catalog # 475729 and 12816001.
Terminated		 JPAK860719
May 14, 2003Roche Diagnostics Corp.
CoaguChek Pro DM meter; catalog # 1894048 and 1893211.
Terminated		 JPAK983892
Apr 10, 2003Roche Diagnostics Corp.
CoaguChek PT test strips, sold in 12 pack.
Terminated		 JPAK974569

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