Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K171664 ↗

FDA Product Code

GKA

Device Class

Class II

Regulation

21 CFR Part 864.7415

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• Access Ck-Mb Reagents

  Class II

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