VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II— 510(k) K041720
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K041720 for VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II, Substantially Equivalent on 2004-08-25. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code MRR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Recalls naming K041720
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041720.
Data sourced from openFDA. This site is unofficial and independent of the FDA.