Creatine Kinase
K-Number: K160570 · 2016-05-25
ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2016-05-25
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Creatine Kinase is a medical device manufactured by Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-05-25 under approval number K160570. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Creatine Kinase?
Creatine Kinase is a medical device that received FDA 510(k) clearance on 2016-05-25. It is manufactured by Roche Diagnostics Operations (Rdo). The 510(k) number is K160570.
When was Creatine Kinase approved by the FDA?
Creatine Kinase received FDA 510(k) clearance on 2016-05-25, under approval number K160570.
What company makes Creatine Kinase?
Creatine Kinase is manufactured by Roche Diagnostics Operations (Rdo).
What is the FDA product code for Creatine Kinase?
The FDA product code for Creatine Kinase is JHS.
Other Devices by Roche Diagnostics Operations (Rdo)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.