Oxyhemoglobin

FDA product code GGZ · Class II (moderate risk) · 21 CFR 864.7500 · Hematology

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K200204Stat Profile Prime Plus Analyzer SystemGGZ · Traditional Nova Biomedical Corporation04/06/2020SE
K180186Stat Profile Prime Plus Analyzer SystemGGZ · Traditional Nova Biomedical Corporation08/23/2018SE