VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS— 510(k) K993068
Substantially EquivalentOrtho-Clinical Diagnostics
FDA 510(k) clearance K993068 for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS, Substantially Equivalent on 1999-10-04. 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
- Special
- Location
- Rochester, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.