GKL · Class II · 21 CFR 864.5200

FDA Product Code GKL: Counter, Cell, Automated (particle Counter)

Leading manufacturers include Coulter Electronics, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Technicon Instruments Corp..

130
Total
130
Cleared
84d
Avg days
1976
Since
130 devices
25–48 of 130
Cleared Aug 30, 1985
COULTER VOLUME ADAPTER
K851943
Coulter Electronics, Inc.
Hematology · 119d
Cleared Jul 30, 1985
COULTER CHANNELYZER 256
K851736
Coulter Electronics, Inc.
Hematology · 96d
Cleared Dec 05, 1984
COULTER COUNTER MODEL M4
K843303
Coulter Electronics, Inc.
Hematology · 104d
Cleared Nov 13, 1984
COULTER COUNTER MODEL ZM
K843164
Coulter Electronics, Inc.
Hematology · 92d
Cleared Jul 27, 1984
COULTER AUTOMATIC SAMPLE HANDLER
K842346
Coulter Electronics, Inc.
Hematology · 43d
Cleared Apr 17, 1984
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 62d
Cleared Feb 10, 1984
COULTER COUNTER M2
K834568
Coulter Electronics, Inc.
Hematology · 43d
Cleared Jan 30, 1984
RDW PARAMETER FOR THE TECHNICON H6000
K834026
Technicon Instruments Corp.
Hematology · 69d
Cleared Sep 12, 1983
TECHNICON H6000 SYSTEM
K832627
Technicon Instruments Corp.
Hematology · 39d
Cleared Sep 01, 1983
FACS ANALYZER
K832420
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 41d
Cleared Apr 27, 1983
QBC CENTRIFUGAL HEMATOLOGY SYS
K830451
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 71d
Cleared Mar 01, 1983
PROFILE 750 BLOOD CELL COUNTER
K823886
Mallinckrodt Critical Care
Hematology · 64d
Cleared Aug 12, 1981
TECHNICON H6000 (90/HR) HEMATOLOGY SYS
K811978
Technicon Instruments Corp.
Hematology · 30d
Cleared Apr 03, 1981
SERIES 810 PLATELET ANALYZER
K803128
J.T. Baker Chemical Co.
Hematology · 112d
Cleared Dec 11, 1980
PLATELET COUNTING KIT
K802636
Streck Laboratories, Inc.
Hematology · 49d
Cleared Sep 17, 1980
LEUKOCYTE VOL. ANALYSIS APPARATUS
K802208
Coulter Electronics, Inc.
Hematology · 6d
Cleared Jun 09, 1980
TECHNICON H6000 HEMATOLOGY SYSTEM
K801155
Technicon Instruments Corp.
Hematology · 26d
Cleared Jan 29, 1980
COULTER COUNTER MODEL S PLUS
K792537
Coulter Electronics, Inc.
Hematology · 50d
Cleared Jan 29, 1980
COULTER COUNTER-BLOOD CELL COUNTER
K792668
Coulter Electronics, Inc.
Hematology · 33d
Cleared Oct 27, 1978
HEMO-W SYSTEM
K781628
Coulter Electronics, Inc.
Hematology · 32d
Cleared Nov 09, 1977
COUNTER MODEL S PLUS BLOOD CELL COUNTER
K771512
Coulter Electronics, Inc.
Chemistry · 93d
Cleared Nov 07, 1977
AUTO. LEUCOCYTE DIFFER. ANALYZER D/90
K771728
Technicon Instruments Corp.
Hematology · 54d
Cleared Oct 07, 1977
DETECTOTERGE AZIDE FREE
K771790
J.T. Baker Chemical Co.
Hematology · 17d
Cleared May 06, 1977
HEMALOG 8/90
K770666
Technicon Instruments Corp.
Hematology · 28d