510(k) K023875 ยท CIX Bromcresol Green Dye-Binding, Albumin
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 10, 2002 |
| Received | Nov 21, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211
VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 C Terminated |
CIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.