Cleared Traditional

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

K140448 · Becton, Dickinson & CO · Microbiology
May 2014
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K140448 is an FDA 510(k) clearance for the BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on May 20, 2014, 88 days after receiving the submission on February 21, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K140448 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2014
Decision Date May 20, 2014
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSL — Dna-reagents, Neisseria
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3390

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