510(k) K122718

BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP by Becton, Dickinson and Company — Product Code GTY

K122718 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP". The FDA issued a decision of Substantially Equivalent on February 6, 2013. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.