510(k) K954257

QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) by Quidel Corp. — Product Code GTZ

K954257 is an FDA 510(k) premarket notification submitted by Quidel Corp. for the device "QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on October 20, 1995. The device falls under product code GTZ (Antisera, 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.