510(k) K885053

BIOTROL URINE PROTEINS REAGENT by Biotrol, USA, Inc. — Product Code JIR

K885053 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL URINE PROTEINS REAGENT". The FDA issued a decision of Substantially Equivalent on January 30, 1989. The device falls under product code JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.