VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;— 510(k) K052645
Substantially EquivalentOrtho-Clinical Diagnostics
FDA 510(k) clearance K052645 for VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;, Substantially Equivalent on 2005-12-14. Applicant: Ortho-Clinical Diagnostics.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics
- Product code
- Code GTQ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.