510(k) K840606 ยท CIG Diazo Colorimetry, Bilirubin
EKTACHEM CLINICAL CHEM. SLIDES
| Applicant | Eastman Kodak Company, Walker MI, US |
| Decision | Substantially Equivalent, Apr 4, 1984 |
| Received | Feb 10, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840606
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrati Terminated |
CIG | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365
VITROS BuBc Slides quantitatively measure unconjugated bi Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.