The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Xpress Strep A.
| Device ID | K172126 |
| 510k Number | K172126 |
| Device Name: | Xpert Xpress Strep A |
| Classification | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| Applicant | Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Contact | Yi-ping Lin |
| Correspondent | Jim Kelly Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Product Code | PGX |
| CFR Regulation Number | 866.2680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-14 |
| Decision Date | 2017-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940006372 | K172126 | 000 |
| 07332940002503 | K172126 | 000 |