The following data is part of a premarket notification filed by Sekisui Diagnostics, Llc with the FDA for Osom Influenza A&b Test Model 190.
| Device ID | K123182 |
| 510k Number | K123182 |
| Device Name: | OSOM INFLUENZA A&B TEST MODEL 190 |
| Classification | Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Applicant | SEKISUI DIAGNOSTICS, LLC 6659 Top Gun St San Diego, CA 92121 |
| Contact | Mark Stavro |
| Correspondent | Mark Stavro SEKISUI DIAGNOSTICS, LLC 6659 Top Gun St San Diego, CA 92121 |
| Product Code | GNX |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-10 |
| Decision Date | 2012-11-05 |
| Summary: | summary |