510(k) K884516

FITC MURINE MONOCLONAL ANTI-RSV IGG by Whittaker Bioproducts, Inc. — Product Code GQG

K884516 is an FDA 510(k) premarket notification submitted by Whittaker Bioproducts, Inc. for the device "FITC MURINE MONOCLONAL ANTI-RSV IGG". The FDA issued a decision of Substantially Equivalent on January 13, 1989. 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. Whittaker Bioproducts, Inc. has at least 10 other 510(k) clearances on record.