Cleared Traditional

APTIMA COMBO 2 ASSAY

K111409 · Gen-Probe, Inc. · Microbiology
May 2012
Decision
350d
Days
Class 2
Risk

About This 510(k) Submission

K111409 is an FDA 510(k) clearance for the APTIMA COMBO 2 ASSAY, 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 May 3, 2012, 350 days after receiving the submission on May 19, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K111409 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2011
Decision Date May 03, 2012
Days to Decision 350 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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