CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL— 510(k) K080570

Name: FDA 510(k) clearance K080570
Creator: U.S. Food and Drug Administration
Published: 2008-09-30

Substantially Equivalent

Centers for Disease Control and Prevention

FDA 510(k) clearance K080570 for CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL, Substantially Equivalent on 2008-09-30. Applicant: Centers for Disease Control and Prevention. Device class: 2.

Clearance details

Applicant: Centers for Disease Control and Prevention
Product code: Code NXD
Device class: Class 2
Regulation: 21 CFR 866.3332
Advisory panel: Microbiology
Date received: 2008-02-29
Decision date: 2008-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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