510(k) K851253

TDX ANALYZER W/NEPHELOMETRY CAROUSEL by Abbott Laboratories — Product Code JQX

K851253 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX ANALYZER W/NEPHELOMETRY CAROUSEL". The FDA issued a decision of Substantially Equivalent on April 30, 1985. The device falls under product code JQX (Nephelometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2700. Abbott Laboratories has at least 10 other 510(k) clearances on record.