Accuclot Thrombin Time Reagent Model A8713/A4589

No FDA recalls on record, checked 12 Oct 2026.

510(k) Number

K982209 ↗

FDA Product Code

GJA

Device Class

Class II

Regulation

21 CFR Part 864.7875

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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