The following data is part of a premarket notification filed by Copan Italia S.p.a. with the FDA for Copan Fecalswab Collection, Transport And Preservation System.
| Device ID | K142094 |
| 510k Number | K142094 |
| Device Name: | COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | COPAN ITALIA S.P.A. 62 FOREST STREE, SUITE 300 Marlborough, MA 01752 |
| Contact | Tina Wu |
| Correspondent | Tina Wu COPAN ITALIA S.P.A. 62 FOREST STREE, SUITE 300 Marlborough, MA 01752 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-01 |
| Decision Date | 2015-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 58053326002194 | K142094 | 000 |
| 38053326000301 | K142094 | 000 |
| 38053326000257 | K142094 | 000 |