The following data is part of a premarket notification filed by Sekisui Diagnostics, Llc with the FDA for Osom Ultra Plus Flu A&b Test Kit.
| Device ID | K192719 |
| 510k Number | K192719 |
| Device Name: | Osom Ultra Plus Flu A&B Test Kit |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | Sekisui Diagnostics, LLC 6659 Top Gun Street San Diego, CA 92121 |
| Contact | Nisha Li |
| Correspondent | Nisha Li Sekisui Diagnostics, LLC 6659 Top Gun Street San Diego, CA 92121 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-04-03 |