510(k) K891286

BIOTROL CHEMISTRY URINE CONTROL by Biotrol, USA, Inc. — Product Code JJW

K891286 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL CHEMISTRY URINE CONTROL". The FDA issued a decision of Substantially Equivalent on April 10, 1989. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.