510(k) K153375

ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls by Abbott Laboratories — Product Code MRG

K153375 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls". The FDA issued a decision of Substantially Equivalent on August 12, 2016. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Abbott Laboratories has at least 10 other 510(k) clearances on record.