Creatine Kinase— 510(k) K160570
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K160570 for Creatine Kinase, Substantially Equivalent on 2016-05-25. Applicant: Roche Diagnostics Operations (Rdo).
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- Product code
- Code JHS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.