GKZ · Class II · 21 CFR 864.5220

FDA Product Code GKZ: Counter, Differential Cell

FDA product code GKZ covers differential cell counters used in hematology laboratories.

These automated or semi-automated instruments classify and count white blood cell subtypes — neutrophils, lymphocytes, monocytes, eosinophils, and basophils — from blood smears or liquid samples. The differential count is a critical component of the complete blood count used to diagnose infections, hematological disorders, and immune conditions.

GKZ devices are Class II medical devices, regulated under 21 CFR 864.5220 and reviewed by the FDA Hematology panel.

Leading manufacturers include Beckman Coulter, Inc., Abbott Laboratories and Coulter Corp..

380
Total
380
Cleared
173d
Avg days
1977
Since
380 devices
73–96 of 380
Cleared May 04, 2005
RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
K050589
Sysmex America, Inc.
Hematology · 57d
Cleared Apr 26, 2005
ABX PENTRA DX 120: OPTION SPS EVOLUTION
K050719
Horiba Abx
Hematology · 36d
Cleared Feb 10, 2005
COULTER LH 750 HEMATOLOGY ANALYZER
K050057
Beckman Coulter, Inc.
Hematology · 30d
Cleared Jan 19, 2005
FLOWCARE PLG CD4 REAGENT
K043215
Beckman Coulter, Inc.
Hematology · 61d
Cleared Nov 23, 2004
FLOWCARE SYSTEM
K041882
Pointcare Technologies, Inc.
Hematology · 134d
Cleared Oct 29, 2004
MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
K042724
Beckman Coulter, Inc.
Hematology · 28d
Cleared Oct 12, 2004
COULTER A T 5DIFF CAP PIERCE (CP)
K042173
Beckman Coulter, Inc.
Hematology · 62d
Cleared Sep 17, 2004
BD FACSCANTO WITH BD FACSANTO SOFTWARE
K041074
Bd Biosciences
Hematology · 144d
Cleared Sep 17, 2004
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K042251
Bayer Healthcare, LLC
Hematology · 28d
Cleared Sep 10, 2004
BD FACS 7-COLOR SETUP BEADS
K040026
Becton Dickinson Immunocytometry Systems
Hematology · 247d
Cleared Sep 10, 2004
BD FACSCANTO SYSTEM
K040725
Becton Dickinson Immunocytometry Systems
Hematology · 172d
Cleared Mar 18, 2004
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
K040073
Sysmex America, Inc.
Hematology · 64d
Cleared Sep 26, 2003
COULTER LH 750 HEMATOLOGY ANALYZER
K032342
Beckman Coulter, Inc.
Hematology · 59d
Cleared Sep 08, 2003
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
K032039
Sysmex America, Inc.
Hematology · 69d
Cleared Sep 08, 2003
ADVIA 60 HEMATOLOGY ANALYZER
K032524
Bayer Healthcare, LLC
Hematology · 24d
Cleared Aug 13, 2003
COULTER LH 500 HEMATOLOGY ANALYZER
K032000
Beckman Coulter, Inc.
Hematology · 64d
Cleared Jul 24, 2003
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
K032013
Beckman Coulter, Inc.
Hematology · 24d
Cleared May 21, 2003
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
K030828
Beckman Coulter, Inc.
Hematology · 68d
Cleared May 12, 2003
CELL-DYN 1800 SYSTEM
K030513
Abbott Laboratories
Hematology · 82d
Cleared Apr 21, 2003
COULTER LH 750 BODY FLUIDS APPLICATION
K030606
Beckman Coulter, Inc.
Hematology · 55d
Cleared Apr 17, 2003
COULTER ACT 5DIFF AUTOLOADER (AL)
K030291
Beckman Coulter, Inc.
Hematology · 79d
Cleared Mar 04, 2003
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A
K030408
Beckman Coulter, Inc.
Hematology · 25d
Cleared Oct 15, 2002
ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
K022668
Bayer Diagnostics Corp.
Hematology · 64d
Cleared Jul 29, 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K022161
Beckman Coulter, Inc.
Hematology · 26d