510(k) K883428

BIOTROL URIC ACID ENZYMATIQUE TRINDER by Biotrol, USA, Inc. — Product Code KNK

K883428 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL URIC ACID ENZYMATIQUE TRINDER". The FDA issued a decision of Substantially Equivalent on September 13, 1988. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.