510(k) K123983

FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS by Qualigen, Inc. — Product Code MRG

K123983 is an FDA 510(k) premarket notification submitted by Qualigen, Inc. for the device "FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS". The FDA issued a decision of Substantially Equivalent on July 3, 2013. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Qualigen, Inc. has at least 10 other 510(k) clearances on record.