The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Xpect Flu A & B.
| Device ID | K092423 |
| 510k Number | K092423 |
| Device Name: | XPECT FLU A & B |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | Thermo Fisher Scientific 12150 SANTA FE DRIVE Lenexa, KS 66215 |
| Contact | Mary A Silvius |
| Correspondent | Mary A Silvius Thermo Fisher Scientific 12150 SANTA FE DRIVE Lenexa, KS 66215 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-07 |
| Decision Date | 2009-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03848838027038 | K092423 | 000 |
| 30848838027032 | K092423 | 000 |