510(k) K173398 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, Apr 26, 2018 |
| Received | Oct 31, 2017 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K173398
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.