Cleared Traditional

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE

K043144 · Gen-Probe, Inc. · Microbiology
Mar 2005
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K043144 is an FDA 510(k) clearance for the GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, 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 March 14, 2005, 119 days after receiving the submission on November 15, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K043144 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2004
Decision Date March 14, 2005
Days to Decision 119 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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