510(k) K902991 ยท GTY Antigens, All Groups, Streptococcus Spp.
ICON STREP B IMMUNOENZYMETRIC ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 3, 1990 |
| Received | Jul 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902991
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.