Cleared Special

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

K123905 · Centers For Disease Control and Prevention · Microbiology
Jan 2013
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K123905 is an FDA 510(k) clearance for the CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, a 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification (Class II — Special Controls, product code OQW), submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on January 14, 2013, 26 days after receiving the submission on December 19, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3332.

Submission Details

510(k) Number K123905 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2012
Decision Date January 14, 2013
Days to Decision 26 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code OQW — 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3332
Definition 2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens

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