KHG

Whole Blood Hemoglobin Determination

Product code
KHG
Device name
Whole Blood Hemoglobin Determination
Device class
Class 2
21 CFR
21 CFR 864.7500
Medical specialty
Hematology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
39 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-09-29.

NumberDecision dateApplicantDevice nameSummary
K2215082023-09-29Sanguina, Inc.AnemoCheck HomePDF

1 summaries are archived here for direct download.

Official FDA classification page: KHG
Classification and pathway per current FDA publications. Data from openFDA (CC0).