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
49–72 of 130
Cleared Jul 27, 1984
COULTER AUTOMATIC SAMPLE HANDLER
K842346
Coulter Electronics, Inc.
Hematology · 43d
Cleared Jun 11, 1984
QUICK-COUNT PLUS 2
K841504
Seragen Diagnostics, Inc.
Hematology · 62d
Cleared Apr 17, 1984
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 62d
Cleared Mar 02, 1984
CELL-DYN 100 WHOLE BLOOD PLATELET
K840170
Abbott Diagnostics
Hematology · 43d
Cleared Feb 10, 1984
PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ
K834372
Diagnostic Technology, Inc.
Hematology · 71d
Cleared Feb 10, 1984
COULTER COUNTER M2
K834568
Coulter Electronics, Inc.
Hematology · 43d
Cleared Jan 30, 1984
QUICK-COUNT
K833971
Seragen Diagnostics, Inc.
Hematology · 75d
Cleared Jan 30, 1984
RDW PARAMETER FOR THE TECHNICON H6000
K834026
Technicon Instruments Corp.
Hematology · 69d
Cleared Sep 26, 1983
CELL-DYN 900 HEMATOLOGY ANALYZER
K832643
Abbott Diagnostics
Hematology · 53d
Cleared Sep 12, 1983
TECHNICON H6000 SYSTEM
K832627
Technicon Instruments Corp.
Hematology · 39d
Cleared Sep 01, 1983
FACS ANALYZER
K832420
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 41d
Cleared Jul 18, 1983
CELL-DYN 400 HEMOTOLOGY ANALYZER
K831368
Abbott Diagnostics
Hematology · 83d
Cleared Jul 18, 1983
CELL-DYN 300 HEMATOLOGY ANALYZER
K832038
Abbott Diagnostics
Hematology · 24d
Cleared May 13, 1983
SYSMEX CC-170
K830507
Toa Medical Electronics USA, Inc.
Hematology · 85d
Cleared May 09, 1983
SYSMEX CC-130
K830505
Toa Medical Electronics USA, Inc.
Hematology · 81d
Cleared May 09, 1983
SYSMEX CC-150
K830506
Toa Medical Electronics USA, Inc.
Hematology · 81d
Cleared May 09, 1983
SYSMEX CC-180
K830508
Toa Medical Electronics USA, Inc.
Hematology · 81d
Cleared Apr 27, 1983
QBC CENTRIFUGAL HEMATOLOGY SYS
K830451
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 71d
Cleared Mar 01, 1983
PROFILE 750 BLOOD CELL COUNTER
K823886
Mallinckrodt Critical Care
Hematology · 64d
Cleared Dec 28, 1982
HEMATOLOGY ANALYZER
K823344
Abbott Diagnostics
Hematology · 50d
Cleared Oct 18, 1982
SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY
K822758
Toa Medical Electronics USA, Inc.
Hematology · 34d
Cleared Aug 12, 1981
TECHNICON H6000 (90/HR) HEMATOLOGY SYS
K811978
Technicon Instruments Corp.
Hematology · 30d
Cleared Jun 09, 1981
CELL DYN 800 HEMATOLOGY ANALYZER
K803218
Abbott Diagnostics
Hematology · 173d
Cleared Apr 03, 1981
SERIES 810 PLATELET ANALYZER
K803128
J.T. Baker Chemical Co.
Hematology · 112d