The following data is part of a premarket notification filed by Remel Inc with the FDA for Xpect Influenza A/b.
| Device ID | K031565 |
| 510k Number | K031565 |
| Device Name: | XPECT INFLUENZA A/B |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | REMEL INC 12076 SANTA FE DRIVE Lenexa, KS 66215 |
| Contact | Mary Ann Silvius |
| Correspondent | Mary Ann Silvius REMEL INC 12076 SANTA FE DRIVE Lenexa, KS 66215 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2003-07-17 |
| Summary: | summary |