510(k) K091657 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
IMMUNOSCAN CCPLUS
| Applicant | Euro-Diagnostica AB, Malmo, SE |
| Decision | Substantially Equivalent, Nov 19, 2009 |
| Received | Jun 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091657
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2018 | Euro Diagnostica AB Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. Terminated |
NHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.