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

FDA 510(k) Cleared Counter, Cell, Automated (particle Counter) Devices (Product Code GKL)

130 devices
1–24 of 130
Cleared May 27, 2016
Glocyte Automated Cell Counter System
K152776
Advanced Instruments, Inc.
Hematology · 245d
Cleared Aug 31, 2010
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
K091539
Iris Diagnostics
Hematology · 462d
Cleared Oct 25, 2007
HEMOCUE WBC SYSTEM
K071652
Hemocue AB
Hematology · 129d
Cleared Dec 07, 2005
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K051693
Bayer Healthcare, LLC
Hematology · 167d
Cleared Mar 23, 2005
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
K050235
Iris International, Inc.
Hematology · 50d
Cleared Feb 11, 2004
SYSMEX POCH-100I
K032677
Sysmex America, Inc.
Hematology · 166d
Cleared Sep 11, 2002
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
K022331
Bayer Diagnostics Corp.
Hematology · 55d
Cleared Aug 21, 2000
SYSMEX R-500
K001683
Sysmex Corporation of America
Hematology · 81d
Cleared May 11, 1999
COULTER Z2 ANALYZER
K991070
Coulter Corp.
Hematology · 41d
Cleared Nov 03, 1998
SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500
K981950
Sysmex Corp.
Hematology · 153d
Cleared Aug 14, 1998
SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
K981761
Sysmex Corp.
Hematology · 87d
Cleared Aug 29, 1997
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K971998
Bayer Corp.
Hematology · 91d
Cleared Mar 13, 1997
SYSMEX SE/RAM-1
K964375
Sysmex Corp.
Hematology · 132d
Cleared Oct 30, 1996
COULTER GEN-S SYSTEM
K962988
Coulter Corp.
Hematology · 90d
Cleared Aug 30, 1996
RETICULOCYTE METHOD
K954607
Bayer Corp.
Hematology · 331d
Cleared Mar 12, 1996
YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
K954006
Intl. Remote Imaging Systems
Hematology · 200d
Cleared Oct 06, 1995
COULTER Z 1
K952308
Coulter Corp.
Hematology · 142d
Cleared Mar 30, 1994
THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY
K934539
Intl. Remote Imaging Systems
Microbiology · 194d
Cleared Jun 22, 1993
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
K930685
Heraeus Kulzer, Inc.
Hematology · 132d
Cleared Sep 22, 1992
QBC HEMACAN HEMATOLOGY SYSTEM
K923121
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 88d
Cleared Jun 29, 1992
IVOS ANALYZER
K920719
Hamilton Thorne Research
Hematology · 132d
Cleared May 01, 1992
YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
K914256
Intl. Remote Imaging Systems
Hematology · 221d
Cleared Sep 10, 1991
SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER
K912494
Toa Medical Electronics USA, Inc.
Hematology · 97d
Cleared Jul 26, 1991
SYSMEX F-810
K910849
Toa Medical Electronics USA, Inc.
Hematology · 149d

About Product Code GKL - Regulatory Context