510(k) K894544

BIOTROL RUB-E.I.A. TEST G by Biotrol, USA, Inc. — Product Code LFX

K894544 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL RUB-E.I.A. TEST G". The FDA issued a decision of Substantially Equivalent on August 30, 1989. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.