510(k) K864206 ยท GTZ Antisera, All Groups, Streptococcus Spp.
REVEAL COLOUR STREP A ZL16
| Applicant | Wellcome Diagnostics, Research Triangle Pk NC, US |
| Decision | Substantially Equivalent, Jan 13, 1987 |
| Received | Oct 27, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864206
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.