GKG · Class II · 21 CFR 864.6400

FDA Product Code GKG: Centrifuge, Hematocrit

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Separation Technology, Inc. and Fisher Scientific Co., LLC.

11
Total
11
Cleared
86d
Avg days
1982
Since

FDA 510(k) Cleared Centrifuge, Hematocrit Devices (Product Code GKG)

11 devices
1–11 of 11
Cleared Jul 05, 1996
SPUNCRIT (MODEL DRC-40)
K961803
Micro Diagnostics Corp.
Hematology · 57d
Cleared Mar 29, 1996
MULTI-CENTRIFUGE
K955795
Novonx, Inc.
Hematology · 98d
Cleared Mar 23, 1993
MICROHEMATOCRIT ROTOR
K930415
Fisher Scientific Co., LLC
Hematology · 56d
Cleared Feb 05, 1993
SPUNCRIT
K925863
bioMerieux, Inc.
Hematology · 78d
Cleared Jun 09, 1992
HERMLE Z230H
K920207
Labnet Intl., Inc.
Hematology · 145d
Cleared Apr 29, 1992
CRITSPIN MICRO-HEMATOCRIT
K920759
Stat-Spin Technologies
Hematology · 70d
Cleared Sep 23, 1991
HEMATASTAT C-70B
K913128
Separation Technology, Inc.
Hematology · 136d
Cleared Mar 21, 1989
HEMATASTAT H-70
K890849
Separation Technology, Inc.
Hematology · 28d
Cleared Sep 14, 1982
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K821803
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 90d
Cleared Sep 14, 1982
HCT CENTRIFUGE
K822445
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Apr 09, 1982
CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY
K813033
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 163d

About Product Code GKG - Regulatory Context