VITROS XT Chemistry Products TBIL-ALKP Slides— 510(k) K190807
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K190807 for VITROS XT Chemistry Products TBIL-ALKP Slides, Substantially Equivalent on 2019-04-26. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Recalls naming K190807
K-number listed on FDA's recall record- Z-1835-2025 — ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
- Z-2623-2023 — VITROS XT Chemistry Products TBIL-ALKP Slides
- Z-2875-2020 — 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 bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190807.
Data sourced from openFDA. This site is unofficial and independent of the FDA.