GKH · Class I · 21 CFR 864.5240

FDA Product Code GKH: Apparatus, Automated Blood Cell Diluting

Leading manufacturers include Beckman Coulter, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

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 Dec 31, 1990
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
K904795
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 73d

About Product Code GKH - Regulatory Context