Creatine Kinase
K-Number: K160570 · 2016-05-25
Device Summary
Frequently Asked Questions
What is the Creatine Kinase?
Creatine Kinase is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K160570.
When did Creatine Kinase receive FDA 510(k) clearance?
Creatine Kinase received FDA 510(k) clearance on 2016-05-25, under 510(k) number K160570.
Who is the listed applicant for Creatine Kinase?
The FDA 510(k) record lists Roche Diagnostics Operations (Rdo) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Creatine Kinase?
The FDA product code for Creatine Kinase is JHS.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Roche Diagnostics Operations (Rdo) as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.