GKM · Class I · 21 CFR 864.6160

FDA Product Code GKM: Hand-tally, Differential

Leading manufacturers include Instrumentation Laboratory CO and Coulter Electronics, Inc..

4
Total
4
Cleared
68d
Avg days
1977
Since

FDA 510(k) Cleared Hand-tally, Differential Devices (Product Code GKM)

4 devices
1–4 of 4
Cleared Jan 19, 1988
COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA
K874188
Coulter Electronics, Inc.
Hematology · 97d
Cleared Apr 04, 1984
MANUAL BLOOD CELL COUNTING DEVICE
K841026
Instrumentation Laboratory CO
Hematology · 23d

About Product Code GKM - Regulatory Context