VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2— 510(k) K012593
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K012593 for VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2, Substantially Equivalent on 2001-08-30. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code LBR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
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Recalls naming K012593
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 K012593.
Data sourced from openFDA. This site is unofficial and independent of the FDA.