Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set— 510(k) K222558

Name: FDA 510(k) clearance K222558
Creator: U.S. Food and Drug Administration
Published: 2022-08-30

Substantially Equivalent

Centers for Disease Control and Prevention

FDA 510(k) clearance K222558 for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set, Substantially Equivalent on 2022-08-30. 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: 2022-08-24
Decision date: 2022-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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K181205 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set2018-09-20

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