Cleared Traditional

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY

K090824 · Becton, Dickinson & CO · Microbiology
Jun 2009
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K090824 is an FDA 510(k) clearance for the BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX 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 June 2, 2009, 68 days after receiving the submission on March 26, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K090824 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2009
Decision Date June 02, 2009
Days to Decision 68 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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