510(k) K063347 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Mar 20, 2007 |
| Received | Nov 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063347
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.