510(k) K991828 ยท GTY Antigens, All Groups, Streptococcus Spp.
STREP B OIA
| Applicant | Biostar, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Aug 19, 1999 |
| Received | May 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991828
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.