510(k) K081338 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 11, 2008 |
| Received | May 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2019 | Roche Diagnostics Operations, Inc. Roche Elecsys Anti-CCP Immunoassay
Catalog # 07251670190 Terminated |
NHX | None listed |
| Aug 23, 2019 | Roche Diagnostics Operations, Inc. Roche Elecsys Anti-CCP Immunoassay
Catalog # 05031656160 Terminated |
NHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.