The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Flu/rsv Xc Assay.
| Device ID | K142045 |
| 510k Number | K142045 |
| Device Name: | XPERT FLU/RSV XC ASSAY |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Scott A Campbell,ph.d.,mba |
| Correspondent | Scott A Campbell,ph.d.,mba CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-28 |
| Decision Date | 2014-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940000783 | K142045 | 000 |