510(k) K974901 ยท LJO Antigen, Iha, Cytomegalovirus
HYBRID CAPTURE SYSTEM CMV DNA ASSAY
| Applicant | Digene Corp., Beltsville MD, US |
| Decision | Substantially Equivalent, Sep 29, 1998 |
| Received | Dec 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974901
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.