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 |