510(k) K041003

IMMUNOCARD TOXINS A & B, MODEL 712050 by Meridian Bioscience, Inc. — Product Code LLH

K041003 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "IMMUNOCARD TOXINS A & B, MODEL 712050". The FDA issued a decision of Substantially Equivalent on August 20, 2004. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.