510(k) K072440 ยท CJY Azo Dye, Calcium
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Sep 20, 2007 |
| Received | Aug 30, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2025 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products Ca Slides;
Catalog Number: 145 0261; Open, Classified |
CJY | None listed |
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT. Open, Classified |
CJY | None listed |
| May 18, 2016 | Ortho-Clinical Diagnostics VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack
Product Usage:
For in vitro Terminated |
CJY | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261
VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/3 Terminated |
CJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.