510(k) K861835

MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST by Syva Co. — Product Code GTH

K861835 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST". The FDA issued a decision of Substantially Equivalent on May 29, 1986. The device falls under product code GTH (Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae), a Class II device regulated under 21 CFR 866.3390. Syva Co. has at least 10 other 510(k) clearances on record.