Cleared Special

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

K251024 · Haemonetics · Hematology

Apr 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K251024 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 (Boston, US). The FDA issued a Cleared decision on April 30, 2025, 28 days after receiving the submission on April 2, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number	K251024 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 2025
Decision Date	April 30, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF