GKH · Class I · 21 CFR 864.5240

FDA Product Code GKH: Apparatus, Automated Blood Cell Diluting

Leading manufacturers include Immunicon Corp., Abbott Diagnostics and Beckman Coulter, Inc..

14
Total
14
Cleared
67d
Avg days
1977
Since

FDA 510(k) Cleared Apparatus, Automated Blood Cell Diluting Devices (Product Code GKH)

14 devices
1–14 of 14
Cleared Aug 26, 2010
CELLTRACKS AUTOPREP SYSTEM MODEL:9541
K100684
Veridex, LLC
Hematology · 169d
Cleared Mar 12, 2004
IMMUNICON CELLTRACKS AUTOPREP SYSTEM
K040077
Immunicon Corp.
Hematology · 58d
Cleared Sep 30, 2002
CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
K022512
Immunicon Corp.
Hematology · 62d
Cleared Jun 11, 2002
COULTER CELLPREP
K021150
Beckman Coulter, Inc.
Hematology · 62d
Cleared Mar 11, 1994
COULTER MULTI Q PREP
K935953
Coulter Corp.
Hematology · 88d
Cleared Oct 14, 1992
COULTER MULTI-Q-PREP
K923530
Coulter Electronics, Inc.
Hematology · 90d
Cleared Dec 31, 1990
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
K904795
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 73d
Cleared Jul 18, 1988
SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
K882767
Toa Medical Electronics USA, Inc.
Hematology · 12d
Cleared Jul 05, 1985
AD150, AUTOMATED HEMATOLOGY DILUTOR
K852373
Abbott Diagnostics
Hematology · 31d
Cleared Oct 01, 1984
HYCEL DILUTOR, VARIOUS MODELS/MULTI
K842747
R&D Systems, Inc.
Hematology · 80d
Cleared Sep 06, 1984
DILU-MATIC 140
K842446
Abbott Diagnostics
Hematology · 77d
Cleared Dec 28, 1982
DILULAB 230
K823522
Innovative Medical Systems, Inc.
Hematology · 29d
Cleared Sep 19, 1979
ROYCO MODEL 371 SUPER DILUTOR
K791644
Royco Instruments
Hematology · 27d
Cleared Feb 07, 1977
MICROSAMPLE BLOOD COLLECTION DEVICE
K761137
Ortho Diagnostics, Inc.
Hematology · 75d

About Product Code GKH - Regulatory Context