Cleared Traditional

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091

K062440 · Gen-Probe, Inc. · Microbiology
Nov 2006
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K062440 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 November 7, 2006, 78 days after receiving the submission on August 21, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K062440 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2006
Decision Date November 07, 2006
Days to Decision 78 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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