510(k) K201269 ยท PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Accula Strep A Test
| Applicant | Mesa Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 9, 2020 |
| Received | May 12, 2020 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K201269
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.