The following data is part of a premarket notification filed by Remel, Inc. with the FDA for Remel Xpect Flu A&b.
| Device ID | K131804 |
| 510k Number | K131804 |
| Device Name: | REMEL XPECT FLU A&B |
| Classification | Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Applicant | REMEL, INC. 12076 Santa Fe Trail Dr Lenexa, KS 66215 |
| Contact | Cindy Knapp |
| Correspondent | Cindy Knapp REMEL, INC. 12076 Santa Fe Trail Dr Lenexa, KS 66215 |
| Product Code | GNX |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-19 |
| Decision Date | 2013-07-12 |
| Summary: | summary |