GKL · Class II · 21 CFR 864.5200

FDA Product Code GKL: Counter, Cell, Automated (particle Counter)

Leading manufacturers include Coulter Electronics, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Technicon Instruments Corp..

130
Total
130
Cleared
84d
Avg days
1976
Since
130 devices
49–72 of 130
Cleared Apr 08, 1977
LATELET DETERMIN. KIT, CAT NO. 2521
K770385
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 39d
Cleared Mar 28, 1977
ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)
K761289
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 98d
Cleared Feb 16, 1977
COUNTER, BLOOD CELL & HEMATOCRIT
K770034
Mallinckrodt Critical Care
Hematology · 37d
Cleared Nov 11, 1976
HA/3 HEMATOLOGY ANALYZER
K760582
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 69d
Cleared Nov 09, 1976
HA/5 HEMATOLOGY ANALYZER
K760581
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 67d