GKL · Class II · 21 CFR 864.5200

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

Leading manufacturers include Coulter Electronics, Inc., Toa Medical Electronics USA, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

130
Total
130
Cleared
84d
Avg days
1976
Since
130 devices
73–96 of 130
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 Feb 08, 1979
ANALYZER, MODEL CC-720
K790026
Sysmex Corp.
Hematology · 36d
Cleared Jan 03, 1979
HYCEL COUNTER 333
K782100
Hycel, Inc.
Hematology · 16d
Cleared Jan 03, 1979
HYCEL COUNTER 222
K782101
Hycel, Inc.
Hematology · 16d
Cleared Jan 03, 1979
HYCEL COUNTER 211
K782102
Hycel, Inc.
Hematology · 16d
Cleared Nov 15, 1978
HEMACHECK
K781562
Vickers America Medical Corp.
Chemistry · 65d
Cleared Oct 27, 1978
HEMO-W SYSTEM
K781628
Coulter Electronics, Inc.
Hematology · 32d
Cleared Jun 28, 1978
SYSMEX AUTO. BLOOD CELL COUNTER, CC-120
K780909
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared Jun 28, 1978
SYSTEM AUTO. BLOOD CELL COUNTER CC-110
K780910
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared Jun 28, 1978
SYSMEX PLATELET COUNTER, PL-110
K780911
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared May 19, 1978
MICROCELL COUNTER MODEL CC-108
K780224
Toa Medical Electronics USA, Inc.
Hematology · 105d
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 Aug 10, 1977
PLATELET COUNTER & HEMATOCRIT ACCES.
K771353
Hycel, Inc.
Hematology · 19d
Cleared Jul 11, 1977
COUNTER 700 & HC-700 HEMO 0 REF.
K771107
Hycel, Inc.
Hematology · 21d
Cleared May 06, 1977
HEMALOG 8/90
K770666
Technicon Instruments Corp.
Hematology · 28d
Cleared Apr 08, 1977
LATELET DETERMIN. KIT, CAT NO. 2521
K770385
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 39d
Cleared Mar 28, 1977
ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)
K761289
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 98d
Cleared Feb 16, 1977
COUNTER, BLOOD CELL & HEMATOCRIT
K770034
Mallinckrodt Critical Care
Hematology · 37d