GKL · Class II · 21 CFR 864.5200

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

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic and Instrumentation Laboratory CO.

130
Total
130
Cleared
84d
Avg days
1976
Since

FDA 510(k) Cleared Counter, Cell, Automated (particle Counter) Devices (Product Code GKL)

130 devices
1–24 of 130
Cleared Sep 22, 1992
QBC HEMACAN HEMATOLOGY SYSTEM
K923121
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 88d
Cleared Dec 28, 1988
FACSMATE SAMPLE HANDLING DEVICE
K885132
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 16d
Cleared Mar 21, 1988
RETICCOUNT SOFTWARE
K880636
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 34d
Cleared Jan 27, 1988
CELLECT LABTRAK SOFTWARE
K874320
Instrumentation Laboratory CO
Hematology · 98d
Cleared Sep 30, 1987
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
K872166
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 117d
Cleared Sep 04, 1986
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
K862374
Instrumentation Laboratory CO
Hematology · 72d
Cleared Sep 04, 1986
IL CELLECT 7
K863290
Instrumentation Laboratory CO
Hematology · 10d
Cleared Sep 04, 1986
IL CELLECT 8
K863291
Instrumentation Laboratory CO
Hematology · 10d
Cleared Apr 17, 1984
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 62d
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 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 Nov 11, 1976
HA/3 HEMATOLOGY ANALYZER
K760582
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 69d
Cleared Nov 09, 1976
HA/5 HEMATOLOGY ANALYZER
K760581
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 67d

About Product Code GKL - Regulatory Context