VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1— 510(k) K001885
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K001885 for VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1, Substantially Equivalent on 2000-07-20. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code CDN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
Recent devices under product code CDN
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- K123322 — ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
- K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
- K103615 — ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
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Recalls naming K001885
K-number listed on FDA's recall record- Z-1837-2025 — ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
- Z-0301-2014 — VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001885.
Data sourced from openFDA. This site is unofficial and independent of the FDA.