Cleared Traditional

APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM

K061413 · Gen-Probe, Inc. · Microbiology
Oct 2006
Decision
144d
Days
Class 1
Risk

About This 510(k) Submission

K061413 is an FDA 510(k) clearance for the APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM, a Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I — General Controls, product code MKZ), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on October 13, 2006, 144 days after receiving the submission on May 22, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K061413 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2006
Decision Date October 13, 2006
Days to Decision 144 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MKZ — Dna Probe, Nucleic Acid Amplification, Chlamydia
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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