510(k) K843347 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
| Applicant | E.I. Dupont DE Nemours & Co., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 5, 1984 |
| Received | Aug 27, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843347
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2003 | Perkinelmer Life Sciences, Inc. Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use
Catalog Number: NEA 103 Terminated |
DHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.