510(k) K944438 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
HEMAGEN CMV IGG KIT
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Feb 20, 1997 |
| Received | Sep 12, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944438
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.