510(k) K884002

ANALYST THEOPHYLLINE ROTOR by The DU Pont Co. — Product Code KLS

K884002 is an FDA 510(k) premarket notification submitted by The DU Pont Co. for the device "ANALYST THEOPHYLLINE ROTOR". The FDA issued a decision of Substantially Equivalent on October 31, 1988. The device falls under product code KLS (Enzyme Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. The DU Pont Co. has at least 10 other 510(k) clearances on record.