Rickettsia Real-time PCR Assay— 510(k) K170940

Name: FDA 510(k) clearance K170940
Creator: U.S. Food and Drug Administration
Published: 2017-06-29

Substantially Equivalent

Centers For Disease Control and Prevention (CDC)

FDA 510(k) clearance K170940 for Rickettsia Real-time PCR Assay, Substantially Equivalent on 2017-06-29. Applicant: Centers For Disease Control and Prevention (CDC). Device class: 2.

Clearance details

Applicant: Centers For Disease Control and Prevention (CDC)
Product code: Code PVQ
Device class: Class 2
Regulation: 21 CFR 866.3316
Advisory panel: Microbiology
Date received: 2017-03-30
Decision date: 2017-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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