510(k) K890395

BIOTROL IRON REAGENT by Biotrol, USA, Inc. — Product Code JIY

K890395 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL IRON REAGENT". The FDA issued a decision of Substantially Equivalent on March 8, 1989. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.