GKH · Class I · 21 CFR 864.5240

FDA Product Code GKH: Apparatus, Automated Blood Cell Diluting

Leading manufacturers include Abbott Diagnostics, Beckman Coulter, Inc. and Ortho Diagnostics, 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 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 Feb 07, 1977
MICROSAMPLE BLOOD COLLECTION DEVICE
K761137
Ortho Diagnostics, Inc.
Hematology · 75d

About Product Code GKH - Regulatory Context