510(k) K850485

ROTOR SYSTEMS A/S-400 & LA/S-400 by E.I. Dupont DE Nemours & Co., Inc. — Product Code JQC

K850485 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ROTOR SYSTEMS A/S-400 & LA/S-400". The FDA issued a decision of Substantially Equivalent on March 12, 1985. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.