510(k) K854081

IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST by Boots-Celltech Diagnostics, Inc. — Product Code GQG

K854081 is an FDA 510(k) premarket notification submitted by Boots-Celltech Diagnostics, Inc. for the device "IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST". The FDA issued a decision of Substantially Equivalent on January 3, 1986. 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. Boots-Celltech Diagnostics, Inc. has at least 10 other 510(k) clearances on record.