Product code GKL— Hematology
A1 SYSTEME 8201/2
- Classification name
- Counter, Cell, Automated (Particle Counter)
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Total cleared
- 130
- First cleared
- Most recent
Clearances under product code GKL — page 2
101–130 of 130- K802208 — LEUKOCYTE VOL. ANALYSIS APPARATUS
- K801545 — ORTHO AUTOMATED CELL COUNTER
- K801155 — TECHNICON H6000 HEMATOLOGY SYSTEM
- K800346 — HEMOSAFE
- K792537 — COULTER COUNTER MODEL S PLUS
- K792668 — COULTER COUNTER-BLOOD CELL COUNTER
- K791867 — ROYCO MODEL 921 CELL COUNTER
- K790026 — ANALYZER, MODEL CC-720
- K782100 — HYCEL COUNTER 333
- K782101 — HYCEL COUNTER 222
- K782102 — HYCEL COUNTER 211
- K781562 — HEMACHECK
- K781628 — HEMO-W SYSTEM
- K781146 — HEMAC LASER HEMATOLOGY SYSTEM
- K780909 — SYSMEX AUTO. BLOOD CELL COUNTER, CC-120
- K780910 — SYSTEM AUTO. BLOOD CELL COUNTER CC-110
- K780911 — SYSMEX PLATELET COUNTER, PL-110
- K780224 — MICROCELL COUNTER MODEL CC-108
- K771512 — COUNTER MODEL S PLUS BLOOD CELL COUNTER
- K771728 — AUTO. LEUCOCYTE DIFFER. ANALYZER D/90
- K771790 — DETECTOTERGE AZIDE FREE
- K771353 — PLATELET COUNTER & HEMATOCRIT ACCES.
- K771107 — COUNTER 700 & HC-700 HEMO 0 REF.
- K770666 — HEMALOG 8/90
- K770385 — LATELET DETERMIN. KIT, CAT NO. 2521
- K761289 — ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)
- K770034 — COUNTER, BLOOD CELL & HEMATOCRIT
- K760765 — WHOLE BLOOD PLATELET COUNTER -2510
- K760582 — HA/3 HEMATOLOGY ANALYZER
- K760581 — HA/5 HEMATOLOGY ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.