510(k) K880157

MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST by Syva Co. — Product Code GON

K880157 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST". The FDA issued a decision of Substantially Equivalent on February 4, 1988. The device falls under product code GON (Antigen, Cf (Including Cf Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Syva Co. has at least 10 other 510(k) clearances on record.