510(k) K072393 ยท LSW Anti-Dna Antibody, Antigen And Control
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, Dec 7, 2007 |
| Received | Aug 27, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2021 | Phadia US Inc EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus Terminated |
LSW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.