510(k) K212623 ยท GTY Antigens, All Groups, Streptococcus Spp.
Healgen Strep A Rapid Test Strip (Throat Swab)
| Applicant | Healgen Scientific,, LLC, Bellaire TX, US |
| Decision | Substantially Equivalent, Mar 16, 2022 |
| Received | Aug 18, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212623
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.