Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set— 510(k) K181205

Name: FDA 510(k) clearance K181205
Creator: U.S. Food and Drug Administration
Published: 2018-09-20

Substantially Equivalent

Centers for Disease Control and Prevention

FDA 510(k) clearance K181205 for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set, Substantially Equivalent on 2018-09-20. Applicant: Centers for Disease Control and Prevention. Device class: 2.

Clearance details

Applicant: Centers for Disease Control and Prevention
Product code: Code PBK
Device class: Class 2
Regulation: 21 CFR 866.3315
Advisory panel: Microbiology
Date received: 2018-05-07
Decision date: 2018-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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