Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K013544 ↗

FDA Product Code

DAP

Device Class

Class II

Regulation

21 CFR Part 864.7320

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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