VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7— 510(k) K152433
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K152433 for VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7, Substantially Equivalent on 2015-09-24. Applicant: Ortho Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
Recent devices under product code DCK
view allMore clearances from Ortho Clinical Diagnostics
view all- K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack
- K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
- K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
- K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack
- K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
Recalls naming K152433
K-number listed on FDA's recall record- Z-1876-2025 — VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
- Z-0535-2025 — VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
- Z-0864-2017 — VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152433.
Data sourced from openFDA. This site is unofficial and independent of the FDA.