The following data is part of a premarket notification filed by Copan Italia S.p.a. with the FDA for Uriswab-urine Collection, Transport And Preservation System.
| Device ID | K180052 |
| 510k Number | K180052 |
| Device Name: | UriSwab-Urine Collection, Transport And Preservation System |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | Copan Italia S.p.A. Via F. Perotti 10 Brescia, IT 25125 |
| Contact | Elisabetta Zanella |
| Correspondent | Melissa M Traylor Melissa M. Traylor 4133 Mayfield Street Santa Maria, CA 93455 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-08 |
| Decision Date | 2018-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28053326003749 | K180052 | 000 |
| 28053326003732 | K180052 | 000 |
| 28053326003725 | K180052 | 000 |
| 28053326003718 | K180052 | 000 |