510(k) K853695

RESPIRATORY SYNCYTIAL VIRUS ID REAGENT by Viromed Laboratories, Inc. — Product Code GQG

K853695 is an FDA 510(k) premarket notification submitted by Viromed Laboratories, Inc. for the device "RESPIRATORY SYNCYTIAL VIRUS ID REAGENT". The FDA issued a decision of Substantially Equivalent on December 4, 1985. 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. Viromed Laboratories, Inc. has at least 10 other 510(k) clearances on record.