GKL · Class II · 21 CFR 864.5200

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

Leading manufacturers include Coulter Electronics, Inc., Toa Medical Electronics USA, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

130
Total
130
Cleared
84d
Avg days
1976
Since
130 devices
25–48 of 130
Cleared Mar 21, 1988
RETICCOUNT SOFTWARE
K880636
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 34d
Cleared Jan 27, 1988
CELLECT LABTRAK SOFTWARE
K874320
Instrumentation Laboratory CO
Hematology · 98d
Cleared Sep 30, 1987
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
K872166
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 117d
Cleared Aug 28, 1987
TECHNICON H*1 JR.(TM) SYSTEM
K873103
Technicon Instruments Corp.
Hematology · 21d
Cleared Sep 04, 1986
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
K862374
Instrumentation Laboratory CO
Hematology · 72d
Cleared Sep 04, 1986
COULTER COUNTER MODEL T-890
K863084
Coulter Electronics, Inc.
Hematology · 23d
Cleared Sep 04, 1986
COULTER COUNTER MODEL T-540
K863085
Coulter Electronics, Inc.
Hematology · 23d
Cleared Sep 04, 1986
IL CELLECT 7
K863290
Instrumentation Laboratory CO
Hematology · 10d
Cleared Sep 04, 1986
IL CELLECT 8
K863291
Instrumentation Laboratory CO
Hematology · 10d
Cleared Aug 06, 1986
COULTER COUNTER MODEL S PLUS JUNIOR
K861780
Coulter Electronics, Inc.
Hematology · 90d
Cleared May 07, 1986
PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
K860586
Diagnostic Technology, Inc.
Hematology · 77d
Cleared Apr 04, 1986
PICOSCALE BLOOD CELL COUNTER, MODEL PS-5
K860166
Diagnostic Technology, Inc.
Hematology · 77d
Cleared Feb 05, 1986
TECHNICON H*1 SYSTEM (HDW)
K853030
Technicon Instruments Corp.
Hematology · 202d
Cleared Nov 05, 1985
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
K853036
Diagnostic Technology, Inc.
Hematology · 110d
Cleared Nov 05, 1985
COULTER COUNTER MODEL T-660
K854114
Coulter Electronics, Inc.
Hematology · 28d
Cleared Oct 10, 1985
COULTER COUNTER MODEL M5
K853429
Coulter Electronics, Inc.
Hematology · 56d
Cleared Aug 30, 1985
COULTER VOLUME ADAPTER
K851943
Coulter Electronics, Inc.
Hematology · 119d
Cleared Jul 30, 1985
COULTER CHANNELYZER 256
K851736
Coulter Electronics, Inc.
Hematology · 96d
Cleared May 13, 1985
SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS
K850171
Toa Medical Electronics USA, Inc.
Hematology · 117d
Cleared Mar 26, 1985
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
K845019
Abbott Diagnostics
Hematology · 89d
Cleared Dec 05, 1984
COULTER COUNTER MODEL M4
K843303
Coulter Electronics, Inc.
Hematology · 104d
Cleared Nov 13, 1984
COULTER COUNTER MODEL ZM
K843164
Coulter Electronics, Inc.
Hematology · 92d
Cleared Oct 23, 1984
BLOOD DILUTION VIAL
K844042
American Scientific Products
Hematology · 6d
Cleared Aug 16, 1984
PICOSCAL BLOOD CELL COUNTER PS-4
K842140
Diagnostic Technology, Inc.
Hematology · 78d