510(k) K041445

IMMUNOCARD STAT! RSV MODEL #750630 by Meridian Bioscience, Inc. — Product Code GQG

K041445 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "IMMUNOCARD STAT! RSV MODEL #750630". The FDA issued a decision of Substantially Equivalent on August 13, 2004. The device falls under product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus), a Class I device regulated under 21 CFR 866.3480. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.