Cleared Traditional

GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS

K043072 · Gen-Probe, Inc. · Microbiology
Jan 2005
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K043072 is an FDA 510(k) clearance for the GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, 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 January 27, 2005, 80 days after receiving the submission on November 8, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K043072 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2004
Decision Date January 27, 2005
Days to Decision 80 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

Similar Devices — MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia

All 18
Aptima? Chlamydia trachomatis Assay
K230451 · Hologic, Inc. · Nov 2023
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K140446 · Becton, Dickinson & CO · May 2014
COBAS 4800 CT / NG TEST
K110923 · Roche Molecular Systems, Inc. · Jan 2012
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K091724 · Becton, Dickinson & CO · Nov 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K090824 · Becton, Dickinson & CO · Jun 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K081824 · Becton, Dickinson & CO · Dec 2008