KQI · Class II · 21 CFR 864.7455

FDA Product Code KQI: Assay, Fetal Hemoglobin

Leading manufacturers include Helena Laboratories.

4
Total
4
Cleared
37d
Avg days
1979
Since

FDA 510(k) Cleared Assay, Fetal Hemoglobin Devices (Product Code KQI)

4 devices
1–4 of 4
Cleared Apr 21, 1988
HBF DILUENT
K880653
Helena Laboratories
Hematology · 64d
Cleared Sep 01, 1981
HELENA HBF QUIPLATE CONTROL
K812226
Helena Laboratories
Hematology · 22d
Cleared Mar 26, 1981
HELENA HEMOGLOBIN F CONTROLS
K810475
Helena Laboratories
Hematology · 31d

About Product Code KQI - Regulatory Context