Thrombomax-Hs with Calcium, Model T6540

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K010158 ↗

FDA Product Code

GGO

Device Class

Class II

Regulation

21 CFR Part 864.7925

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sigma Diagnostics, Inc. →