510(k) K190807 ยท CIG Diazo Colorimetry, Bilirubin
VITROS XT Chemistry Products TBIL-ALKP Slides
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Apr 26, 2019 |
| Received | Mar 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT. Open, Classified |
CJE | None listed |
| Sep 21, 2023 | Ortho-Clinical Diagnostics, INc. VITROS XT Chemistry Products TBIL-ALKP Slides Open, Classified |
CIG | None listed |
| Jul 13, 2020 | Ortho-Clinical Diagnostics VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.