H-1 Setpoint Platelet and Rbc/Wbc Calibrators

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K864664 ↗

FDA Product Code

KSA

Device Class

Class II

Regulation

21 CFR Part 864.8185

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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