GKX · Class II · 21 CFR 864.5200

FDA Product Code GKX: Instrument, Automated Platelet Counting

Leading manufacturers include Abx Diagnostics and Gainor Medical.

2
Total
2
Cleared
54d
Avg days
1984
Since

FDA 510(k) Cleared Instrument, Automated Platelet Counting Devices (Product Code GKX)

2 devices
1–2 of 2
Cleared Feb 28, 2002
ABX MICROS 60 HEMATOLOGY ANALYZER
K014203
Abx Diagnostics
Hematology · 69d
Cleared Aug 14, 1984
CLEAR POROUS PLASTIC-HYPOALLERGENIC
K840948
Gainor Medical
Hematology · 39d

About Product Code GKX - Regulatory Context