510(k) K011097

QUICKVUE DIPSTICK STREP A by Quidel Corp. — Product Code GTY

K011097 is an FDA 510(k) premarket notification submitted by Quidel Corp. for the device "QUICKVUE DIPSTICK STREP A". The FDA issued a decision of Substantially Equivalent on May 8, 2001. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Quidel Corp. has at least 10 other 510(k) clearances on record.