VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1— 510(k) K031924
Substantially EquivalentOrtho-Clinical Diagnostics
FDA 510(k) clearance K031924 for VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1, Substantially Equivalent on 2003-08-07. Applicant: Ortho-Clinical Diagnostics.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics
- Product code
- Code JIT
- Advisory panel
- Clinical Chemistry
- 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.