510(k) K101514

BD DIRECTIGEN EZ RSV by Becton, Dickinson & CO — Product Code GQG

K101514 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD DIRECTIGEN EZ RSV". The FDA issued a decision of Substantially Equivalent on July 9, 2010. 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. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.