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.
Device ID | K201849 |
510k Number | K201849 |
Device Name: | ENAT Molecular Collection And Preservation Medium |
Classification | Microbial Nucleic Acid Storage And Stabilization Device |
Applicant | Copan Italia S.p.A. Via F. Perotti 10 Brescia, IT 25125 |
Contact | Elena Simeonato |
Correspondent | Elena Simeonato Copan Italia S.p.A. Via F. Perotti 10 Brescia, IT 25125 |
Product Code | QBD |
CFR Regulation Number | 866.2950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-06 |
Decision Date | 2020-09-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
58053326009704 | K201849 | 000 |
58053326009698 | K201849 | 000 |
58053326009681 | K201849 | 000 |