510(k) K981567

HYBRID CAPTURE II CT/GC TEST by Digene Corp. — Product Code LSL

K981567 is an FDA 510(k) premarket notification submitted by Digene Corp. for the device "HYBRID CAPTURE II CT/GC TEST". The FDA issued a decision of Substantially Equivalent on February 29, 2000. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Digene Corp. has at least 8 other 510(k) clearances on record.