510(k) K251697

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip by ACON Laboratories, Inc. — Product Code GTY

K251697 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip". The FDA issued a decision of Substantially Equivalent on November 26, 2025. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.