eNAT molecular collection and preservation medium— 510(k) K201849

Name: FDA 510(k) clearance K201849
Creator: U.S. Food and Drug Administration
Published: 2020-09-17

Substantially Equivalent

Copan Italia Spa

FDA 510(k) clearance K201849 for eNAT molecular collection and preservation medium, Substantially Equivalent on 2020-09-17. Applicant: Copan Italia Spa. Device class: 2.

Clearance details

Applicant: Copan Italia Spa
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2020-07-06
Decision date: 2020-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brescia, IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.