510(k) K001767 ยท LJO Antigen, Iha, Cytomegalovirus
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Aug 7, 2000 |
| Received | Jun 12, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001767
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.