VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS— 510(k) K062165
Substantially EquivalentOrtho-Clinical Diagnostics
FDA 510(k) clearance K062165 for VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS, Substantially Equivalent on 2007-01-05. Applicant: Ortho-Clinical Diagnostics.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics
- Product code
- Code DIS
- Advisory panel
- Clinical Toxicology
- 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.