Cleared Traditional

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY

K081824 · Becton, Dickinson & CO · Microbiology
Dec 2008
Decision
167d
Days
Class 1
Risk

About This 510(k) Submission

K081824 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 December 11, 2008, 167 days after receiving the submission on June 27, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K081824 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2008
Decision Date December 11, 2008
Days to Decision 167 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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