510(k) K980759 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Apr 23, 1998 |
| Received | Feb 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2012 | Diamedix Corporation Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmf Terminated |
LLL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.