510(k) K232587

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer by Shenzhen New Industries Biomedical Engineering Co., Ltd. — Product Code MRG

K232587 is an FDA 510(k) premarket notification submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. for the device "MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer". The FDA issued a decision of Substantially Equivalent on April 12, 2024. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Shenzhen New Industries Biomedical Engineering Co., Ltd. has at least 4 other 510(k) clearances on record.