The following data is part of a premarket notification filed by Savyon Diagnostics, Ltd. with the FDA for Diaslide Urine Culturing Device.
| Device ID | K921045 |
| 510k Number | K921045 |
| Device Name: | DIASLIDE URINE CULTURING DEVICE |
| Classification | Kit, Screening, Urine |
| Applicant | SAVYON DIAGNOSTICS, LTD. KIRYAT MINRAV HABOSEM 3, Ashdod, IL 77101 |
| Contact | Hana Gasassi |
| Correspondent | Hana Gasassi SAVYON DIAGNOSTICS, LTD. KIRYAT MINRAV HABOSEM 3, Ashdod, IL 77101 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-04 |
| Decision Date | 1992-09-28 |