510(k) K061165 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
| Applicant | Sweden Diagnostics (Us), Inc., Portage MI, US |
| Decision | Substantially Equivalent, Aug 3, 2006 |
| Received | Apr 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061165
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2017 | Phadia US Inc EliA Sample Diluent, Article number, 83-1023-01 Terminated |
NHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.