510(k) K812013 ยท GTX Antisera, Fluorescent, All Groups, Streptococcus Spp.
FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
| Applicant | Springwood Microbiologicals, Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 28, 1981 |
| Received | Jul 17, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812013
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.