ENAT Molecular Collection And Preservation Medium

Microbial Nucleic Acid Storage And Stabilization Device

Copan Italia S.p.A.

The following data is part of a premarket notification filed by Copan Italia S.p.a. with the FDA for Enat Molecular Collection And Preservation Medium.

Pre-market Notification Details

Device IDK201849
510k NumberK201849
Device Name:ENAT Molecular Collection And Preservation Medium
ClassificationMicrobial Nucleic Acid Storage And Stabilization Device
Applicant Copan Italia S.p.A. Via F. Perotti 10 Brescia,  IT 25125
ContactElena Simeonato
CorrespondentElena Simeonato
Copan Italia S.p.A. Via F. Perotti 10 Brescia,  IT 25125
Product CodeQBD  
CFR Regulation Number866.2950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-06
Decision Date2020-09-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
58053326009704 K201849 000
58053326009698 K201849 000
58053326009681 K201849 000

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