510(k) K121608 ยท MRG System, Test, Vitamin D
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 15, 2013 |
| Received | Jun 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121608
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2014 | Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.