Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with Cdm Software, Cdm Software

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K130860 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K063643 Active Cleared 27 Dec 2006