VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659— 510(k) K071801
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K071801 for VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659, Substantially Equivalent on 2007-07-20. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
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Recalls naming K071801
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-0268-2020 — VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
- Z-3043-2018 — VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
- Z-3044-2018 — VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage 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. Product Usage:
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071801.
Data sourced from openFDA. This site is unofficial and independent of the FDA.