HBA1C - Control Normal, Control Abnormal

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

510(k) Number

K063209 ↗

FDA Product Code

LCP

Models / Variants

HBA1C

Calibrator

Control Normal, Control Abnormal

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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