510(k) K862133 ยท GTY Antigens, All Groups, Streptococcus Spp.
HYGEIA RAPID STREP A TEST
| Applicant | Hygeia Sciences, Newton MA, US |
| Decision | Substantially Equivalent, Jun 25, 1986 |
| Received | Jun 4, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862133
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.