510(k) K061509

TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 by Gen-Probe, Inc. — Product Code LSL

K061509 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196". The FDA issued a decision of Substantially Equivalent on October 4, 2006. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.