510(k) K023285 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Oct 9, 2002 |
| Received | Sep 16, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023285
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 3, 2006 | Axis-Shield Diagnostics, Ltd. Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200) Terminated |
NHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.