510(k) K961196 ยท CDN Urease, Photometric, Urea Nitrogen
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 15, 1996 |
| Received | Mar 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961196
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204
VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) o Terminated |
CDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.