510(k) K041799 ยท NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Aug 25, 2004 |
| Received | Jul 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041799
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2017 | Ortho-Clinical Diagnostics VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integr Terminated |
JIT | None listed |
| Jun 16, 2014 | Ortho-Clinical Diagnostics VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VI Terminated |
JIT | None listed |
| Jun 16, 2014 | Ortho-Clinical Diagnostics VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Terminated |
DKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.