K160570

Substantially Equivalent

Creatine Kinase

Applicant: Roche Diagnostics Operations (Rdo)
Product code: JHS
Advisory panel: Clinical Chemistry
Date received: 2016-02-29
Decision date: 2016-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, MD, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.