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510(k) K183160

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge by Haemonetics Corporation — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2019
Date Received
November 15, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Haemonetics Corporation

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  • K160502 — TEG 6s Hemostasis System (April 19, 2017)
  • K162423 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (January 3, 2017)
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Other clearances for product code JPA

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  • K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (January 15, 2025)
  • K232018 — Citrated: K, KH, RTH, FFH (March 29, 2024)
  • K233790 — ACL TOP 970 CL (December 29, 2023)
  • K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein (September 29, 2023)
  • K212183 — STA R Max 3, STA Compact Max 3 (June 7, 2023)
  • K201440 — ROTEM sigma Thromboelastometry System (July 8, 2022)
  • K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (A (December 29, 2021)
  • K193041 — Hemochron Signature Elite (November 22, 2019)