U.V. Spectrometry, Theophylline

FDA product code LCY · Class II (moderate risk) · 21 CFR 862.3880 · Clinical Toxicology

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K891761GDS Enzymatic Theophylline ReagentLCY · Traditional Gds Diagnostics05/16/1989SE
K780442Theophylline Assay to the GemsaecLCY · Traditional Syva Co.04/12/1978SE
K780441Theophylline Assay to the CentrifichemLCY · Traditional Syva Co.04/12/1978SE