510(k) K010893

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 by Digene Corp. — Product Code LSL

K010893 is an FDA 510(k) premarket notification submitted by Digene Corp. for the device "MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01". The FDA issued a decision of Substantially Equivalent on September 24, 2001. 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.