The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Flu Genexpert Dx Systems (gx-i, Gx-iv).
| Device ID | K120911 |
| 510k Number | K120911 |
| Device Name: | XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) |
| 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 | 2012-03-26 |
| Decision Date | 2012-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940007720 | K120911 | 000 |
| 07332940007713 | K120911 | 000 |