510(k) K183366 ยท PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
GenePOC Strep A
| Applicant | Genepoc, Inc., Quebec, CA |
| Decision | Substantially Equivalent, Mar 6, 2019 |
| Received | Dec 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183366
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.