510(k) K935809 ยท GQH Antigen, Cf (Including Cf Control), Cytomegalovirus
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
| Applicant | Light Diagnostics, Temecula CA, US |
| Decision | Substantially Equivalent, May 5, 1994 |
| Received | Dec 2, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935809
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.