VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System— 510(k) K182063
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K182063 for VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System, Substantially Equivalent on 2018-10-30. 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
- Traditional
- Location
- Rochester, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.