GKF · Class II · 21 CFR 864.5600

FDA Product Code GKF: Instrument, Hematocrit, Automated

Leading manufacturers include Nova Biomedical Corp., Fisher Scientific Co., LLC and Instrumentation Laboratory CO.

15
Total
15
Cleared
84d
Avg days
1978
Since

FDA 510(k) Cleared Instrument, Hematocrit, Automated Devices (Product Code GKF)

15 devices
1–15 of 15
Cleared Dec 14, 2016
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
K160415
Instrumentation Laboratory CO
Chemistry · 306d
Cleared May 27, 1999
CRIT-SCAN II MONITOR
K983551
In-Line Diagnostics Corp.
Hematology · 230d
Cleared May 12, 1998
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
K981425
Nova Biomedical Corp.
General & Plastic Surgery · 26d
Cleared May 12, 1998
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
K981426
Nova Biomedical Corp.
Hematology · 26d
Cleared May 12, 1998
STAT PROFILE M ANALYZER
K981427
Nova Biomedical Corp.
Hematology · 26d
Cleared Mar 11, 1992
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE
K915825
Fisher Scientific Co., LLC
Hematology · 72d
Cleared Jan 08, 1992
MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
K915441
Fisher Scientific Co., LLC
Hematology · 35d
Cleared Dec 27, 1990
NEW COBE SATURATION/HEMATOCRIT MONITOR
K904336
Cobe Laboratories, Inc.
Hematology · 98d
Cleared Jan 05, 1987
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
K864646
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 41d
Cleared Feb 04, 1981
STAT-CRIT HEMATOCRIT MEASURING INSTRU
K802199
United States Surgical, A Division of Tyco Healthc
Hematology · 147d
Cleared Aug 14, 1978
CUTTER/COMPUR MINI CENTRIFUGE
K781059
Cutter Laboratories, Inc.
Hematology · 49d

About Product Code GKF - Regulatory Context