Instrument, Automated Platelet Counting

FDA product code GKX · Class II (moderate risk) · 21 CFR 864.5200 · Hematology

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K014203Abx Micros 60 Hematology AnalyzerGKX · Traditional Abx Diagnostics02/28/2002SE
K840948Clear Porous Plastic-HypoallergenicGKX · Traditional Gainor Medical08/14/1984SE