510(k) K840880 ยท CIG Diazo Colorimetry, Bilirubin
EKTACHEM CLINICAL CHEM. SLIDES
| Applicant | Eastman Kodak Company, Walker MI, US |
| Decision | Substantially Equivalent, Apr 18, 1984 |
| Received | Feb 27, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840880
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive Terminated |
CIG | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931
VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.