The following data is part of a premarket notification filed by Sekisui Diagnostics, Llc with the FDA for Acucy Influenza A&b Test With The Acucy System.
| Device ID | K182001 |
| 510k Number | K182001 |
| Device Name: | Acucy Influenza A&B Test With The Acucy System |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | Sekisui Diagnostics, LLC 6659 Top Gun St. San Diego, CA 92121 |
| Contact | Shelly Harris |
| Correspondent | Shelly Harris Sekisui Diagnostics, LLC 6659 Top Gun St. 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 | 2018-07-26 |
| Decision Date | 2018-12-17 |
| Summary: | summary |