VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS— 510(k) K042476
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K042476 for VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS, Substantially Equivalent on 2004-12-01. Applicant: Ortho-Clinical Diagnostics, Inc..
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code LEG
- 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.