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JPA — System, Multipurpose For In Vitro Coagulation Studies Class II

FDA Device Classification

Classification Details

Product Code
JPA
Device Class
Class II
Regulation Number
864.5425
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250965sysmex americaAutomated Blood Coagulation Analyzer CN-Series (CN-6000)June 2, 2025
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K232018haemonetics corporationCitrated: K, KH, RTH, FFHMarch 29, 2024
K233790instrumentation laboratoryACL TOP 970 CLDecember 29, 2023
K221359instrumentation laboratoryACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 GlycoproteinSeptember 29, 2023
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K201440tem innovationsROTEM sigma Thromboelastometry SystemJuly 8, 2022
K202101accriva diagnosticsGEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ADecember 29, 2021
K193041accriva diagnosticsHemochron Signature EliteNovember 22, 2019
K183390diagnostic grifolsQNext and DG-PTAugust 21, 2019
K183160haemonetics corporationTEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeMay 9, 2019
K173202sekisui medical coCP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia ConMay 9, 2018
K172286siemens healthcare diagnostic productsAutomated Blood Coagulation Analyzer CS-2500December 18, 2017
K172333siemens healthcare diagnostics productsSysmex CS-5100October 31, 2017
K160502haemonetics corporationTEG 6s Hemostasis SystemApril 19, 2017
K170314instrumentation laboratoryACL AcuStarMarch 3, 2017
K162688siemens healthcare diagnostics productsSysmex CS-2100iDecember 26, 2016
K162420siemens healthcare diagnostics productsSysmex Automated Blood Coagulation Analyzer CS-5100December 12, 2016
K161317siemens healthcare diagnostics productsSysmex Automated Blood Coagulation Analyzer CS-5100September 2, 2016