LCY — U.V. Spectrometry, Theophylline Class II

FDA Device Classification

FDA product code LCY covers "U.V. Spectrometry, Theophylline", a Class II medical device regulated under 21 CFR 862.3880. Submissions are reviewed by the Clinical Toxicology panel. At least 3 recent 510(k) clearances have been granted under this product code.