Cleared Traditional

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091

K063664 · Gen-Probe, Inc. · Microbiology
Jan 2007
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K063664 is an FDA 510(k) clearance for the GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on January 25, 2007, 48 days after receiving the submission on December 8, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K063664 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2006
Decision Date January 25, 2007
Days to Decision 48 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSL — Dna-reagents, Neisseria
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3390

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