510(k) K871226

SYPHILIS SEROLOGICAL REAGENTS by New Horizons Diagnostics Co. — Product Code GMQ

K871226 is an FDA 510(k) premarket notification submitted by New Horizons Diagnostics Co. for the device "SYPHILIS SEROLOGICAL REAGENTS". The FDA issued a decision of Substantially Equivalent on May 28, 1987. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820. New Horizons Diagnostics Co. has at least 9 other 510(k) clearances on record.