Cleared Traditional

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY

K091724 · Becton, Dickinson & CO · Microbiology
Nov 2009
Decision
155d
Days
Class 1
Risk

About This 510(k) Submission

K091724 is an FDA 510(k) clearance for the BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY, a Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I — General Controls, product code MKZ), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on November 13, 2009, 155 days after receiving the submission on June 11, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K091724 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2009
Decision Date November 13, 2009
Days to Decision 155 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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