Cleared Traditional

GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088

K053446 · Gen-Probe, Inc. · Microbiology
Jul 2006
Decision
225d
Days
Class 1
Risk

About This 510(k) Submission

K053446 is an FDA 510(k) clearance for the GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088, 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 July 25, 2006, 225 days after receiving the submission on December 12, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K053446 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2005
Decision Date July 25, 2006
Days to Decision 225 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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