510(k) K172126 ยท PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Xpert Xpress Strep A
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 25, 2017 |
| Received | Jul 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172126
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2023 | Cepheid Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only Open, Classified |
PGX | None listed |
| Nov 2, 2023 | Cepheid Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, Open, Classified |
PGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.