510(k) K093954 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
| Applicant | Bio-Rad Laboratories, Benicia CA, US |
| Decision | Substantially Equivalent, Aug 24, 2010 |
| Received | Dec 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093954
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2023 | Bio-Rad Laboratories, Inc. BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD Open, Classified |
NHX | None listed |
| Apr 12, 2023 | Bio-Rad Laboratories, Inc. BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD Open, Classified |
NHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.