The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Flu, Genexpert Dx Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 And 4.0.
| Device ID | K103766 |
| 510k Number | K103766 |
| Device Name: | XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 |
| Classification | 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Kerry J Flom |
| Correspondent | Kerry J Flom CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | OQW |
| Subsequent Product Code | OCC |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 866.3332 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2011-04-21 |
| Summary: | summary |