510(k) K153551 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
| Applicant | Axis-Shield Diagnostics Limited, Dundee, GB |
| Decision | Substantially Equivalent, Aug 4, 2016 |
| Received | Dec 11, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153551
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2019 | Siemens Healthcare Diagnostics, Inc Atellica IM anti-CCP IgG (aCCP) Assay
Siemens Material Number: 10732998 (100 Test)
Test Version1.0 - Product Usage: The ADVIA Centaur Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the se Terminated |
NHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.