510(k) K030626 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 18, 2003 |
| Received | Feb 27, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030626
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990
VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS Terminated |
DCK | None listed |
| Jan 8, 2005 | Ortho-Clinical Diagnostics Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rocheste Terminated |
DCK | None listed |
| Sep 18, 2004 | Ortho-Clinical Diagnostics VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are f Terminated |
DCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.