510(k) K813076

PHOSPHOTUNGSTATE REDUCTION, URIC ACID by American Monitor Corp. — Product Code CDH

K813076 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "PHOSPHOTUNGSTATE REDUCTION, URIC ACID". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code CDH (Acid, Uric, Phosphotungstate Reduction), a Class I device regulated under 21 CFR 862.1775. American Monitor Corp. has at least 10 other 510(k) clearances on record.