The following data is part of a premarket notification filed by Diesse Diagnostica Senese S.p.a with the FDA for Coproset Salmonella And Shigella, Uriset Preservative Tubes And Swab Set General Use.
| Device ID | K070062 |
| 510k Number | K070062 |
| Device Name: | COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE |
| Classification | Device, Specimen Collection |
| Applicant | DIESSE DIAGNOSTICA SENESE S.P.A 1690 W 38 PLACE UNIT B1 Hialeah, FL 33012 |
| Contact | Raul Alvarez |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-01-05 |
| Decision Date | 2007-07-30 |
| Summary: | summary |