510(k) K142373

Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst by Beckman Coulter, Inc. — Product Code MRG

K142373 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst". The FDA issued a decision of Substantially Equivalent on December 22, 2014. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.