510(k) K961226 ยท CJY Azo Dye, Calcium
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 7, 1996 |
| Received | Mar 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.