Cleared Special

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

K243858 · Haemonetics Corporation · Hematology
Jan 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K243858 is an FDA 510(k) clearance for the TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Haemonetics Corporation (Boston, US). The FDA issued a Cleared decision on January 15, 2025, 30 days after receiving the submission on December 16, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K243858 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2024
Decision Date January 15, 2025
Days to Decision 30 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

Similar Devices — JPA System, Multipurpose For In Vitro Coagulation Studies

All 179
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
K250965 · Sysmex America, Inc. · Jun 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
K251024 · Haemonetics · Apr 2025
Citrated: K, KH, RTH, FFH
K232018 · Haemonetics Corporation · Mar 2024
ACL TOP 970 CL
K233790 · Instrumentation Laboratory · Dec 2023
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-?2 Glycoprotein-I IgM
K221359 · Instrumentation Laboratory CO · Sep 2023
STA R Max 3, STA Compact Max 3
K212183 · Diagnostica Stago S.A.S · Jun 2023