510(k) K911417 ยท GTZ Antisera, All Groups, Streptococcus Spp.
ICON STREP B IMMUNOENZYMETRIC ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 24, 1991 |
| Received | Apr 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911417
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.