510(k) K152433 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
| Applicant | Ortho Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Sep 24, 2015 |
| Received | Aug 27, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152433
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2025 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides. Open, Classified |
DCK | None listed |
| Nov 25, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma
Model/Catalog Number: 1926740 Open, Classified |
DCK | None listed |
| Oct 26, 2016 | Ortho-Clinical Diagnostics VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740 Terminated |
DCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.