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FDA 510(k)

eNAT molecular collection and preservation medium

K-Number: K201849 · 2020-09-17

ApplicantCopan Italia Spa
Decision Date2020-09-17
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

eNAT molecular collection and preservation medium is a medical device manufactured by Copan Italia Spa. It received FDA 510(k) clearance on 2020-09-17 under approval number K201849. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eNAT molecular collection and preservation medium?

eNAT molecular collection and preservation medium is a medical device that received FDA 510(k) clearance on 2020-09-17. It is manufactured by Copan Italia Spa. The 510(k) number is K201849.

When was eNAT molecular collection and preservation medium approved by the FDA?

eNAT molecular collection and preservation medium received FDA 510(k) clearance on 2020-09-17, under approval number K201849.

What company makes eNAT molecular collection and preservation medium?

eNAT molecular collection and preservation medium is manufactured by Copan Italia Spa.

What is the FDA product code for eNAT molecular collection and preservation medium?

The FDA product code for eNAT molecular collection and preservation medium is QBD.

Related Clinical Trials

NCT07503301 Small Vessel Disease and Cerebral Infarct Healing InErvation Via Limb Distant Adaptation ENROLLING_BY_INVITATION

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K180052UriSwab-Urine Collection, Transport and Preservation System K220052Copan FecalSwab Collection, Transport and Preservation System K232565UriSponge™ K232357Copan Universal Transport Medium (UTM-RT) System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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