VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208— 510(k) K063591
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K063591 for VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208, Substantially Equivalent on 2006-12-15. Applicant: Ortho-Clinical Diagnostics, Inc..
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code JFY
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
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