VITROS Chemistry Products Cl- Slides— 510(k) K162020
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K162020 for VITROS Chemistry Products Cl- Slides, Substantially Equivalent on 2016-12-16. Applicant: Ortho Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code CGZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1170
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code CGZ
view all- K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
- K170320 — Alinity c ICT Sample Diluent
- K082099 — VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
- K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
- K070531 — ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
More 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 K162020
K-number listed on FDA's recall record- Z-0267-2020 — VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
- Z-3184-2018 — VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162020.
Data sourced from openFDA. This site is unofficial and independent of the FDA.