510(k) K882835 ยท GQH Antigen, Cf (Including Cf Control), Cytomegalovirus
INDIRECT FLUORESCENT ASSAY FOR (HCMV)
| Applicant | Stellar Bio Systems, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Dec 5, 1988 |
| Received | Jul 8, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882835
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.