VITROS Immunodiagnostic Products CK-MB Reagent Pack— 510(k) K212648
Substantially EquivalentOrtho Clinical Diagnostics
FDA 510(k) clearance K212648 for VITROS Immunodiagnostic Products CK-MB Reagent Pack, Substantially Equivalent on 2022-01-28. Applicant: Ortho Clinical Diagnostics.
Clearance details
- Applicant
- Ortho Clinical Diagnostics
- Product code
- Code JHX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pencoed, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.