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

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

130 devices
1–24 of 130
Cleared Dec 07, 2005
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K051693
Bayer Healthcare, LLC
Hematology · 167d
Cleared May 11, 1999
COULTER Z2 ANALYZER
K991070
Coulter Corp.
Hematology · 41d
Cleared Aug 29, 1997
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K971998
Bayer Corp.
Hematology · 91d
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 Oct 06, 1995
COULTER Z 1
K952308
Coulter Corp.
Hematology · 142d
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 Feb 22, 1989
COULTER FLOW RETICULOCYTE REAGENT
K885332
Coulter Electronics, Inc.
Hematology · 56d
Cleared Jan 24, 1989
NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS
K884618
Nova Biomedical Corp.
Hematology · 81d
Cleared Dec 28, 1988
FACSMATE SAMPLE HANDLING DEVICE
K885132
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 16d
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 Feb 05, 1986
TECHNICON H*1 SYSTEM (HDW)
K853030
Technicon Instruments Corp.
Hematology · 202d
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

About Product Code GKL - Regulatory Context