Assay, Bart'S, Hemoglobin

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

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K810976Alpha-Thal Screen TM ControlLGL · Traditional Isolab, Inc.05/29/1981SE
K801771Alpha-Thal Screen 20 Test Kit & 100 KitLGL · Traditional Isolab, Inc.01/16/1981SE