510(k) K884170

ANALYST THEOPHYLLINE CALIBRATOR by The DU Pont Co. — Product Code DLJ

K884170 is an FDA 510(k) premarket notification submitted by The DU Pont Co. for the device "ANALYST THEOPHYLLINE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on November 16, 1988. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. The DU Pont Co. has at least 10 other 510(k) clearances on record.