510(k) K801159 ยท GTZ Antisera, All Groups, Streptococcus Spp.
STREPTO-SEC TM
| Applicant | Organon, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 20, 1980 |
| Received | May 11, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801159
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.