K962549
Substantially EquivalentVIDAS CREATINE KINASE MB ASSAY 30-421
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- JHX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.