510(k) K061008

QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 by Quidel Corp. — Product Code MCE

K061008 is an FDA 510(k) premarket notification submitted by Quidel Corp. for the device "QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199". The FDA issued a decision of Substantially Equivalent on September 8, 2006. The device falls under product code MCE (Respiratory Syncytial Virus - Elisa), a Class I device regulated under 21 CFR 866.3480. Quidel Corp. has at least 10 other 510(k) clearances on record.