Class Class II

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K251024)

K251024 2025-04-30 Special
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Description

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge by Haemonetics, an FDA 510(k) cleared hematology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251024
Clearance Date2025-04-30
Clearance TypeSpecial
Product CodeJPA
Regulation Number864.5425

Categories

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Predicate lineage for K251024

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K251024) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Car...Haemonetics Corporation2025

Trace the full predicate network for K251024

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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