GKF · Class II · 21 CFR 864.5600

FDA Product Code GKF: Instrument, Hematocrit, Automated

Leading manufacturers include Instrumentation Laboratory CO, United States Surgical, A Division of Tyco Healthc and E.I. Dupont DE Nemours & Co., Inc..

15
Total
15
Cleared
84d
Avg days
1978
Since

FDA 510(k) Cleared Instrument, Hematocrit, Automated Devices (Product Code GKF)

15 devices
1–15 of 15
Cleared Dec 14, 2016
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
K160415
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Jan 05, 1987
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
K864646
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 41d
Cleared Feb 04, 1981
STAT-CRIT HEMATOCRIT MEASURING INSTRU
K802199
United States Surgical, A Division of Tyco Healthc
Hematology · 147d

About Product Code GKF - Regulatory Context