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FDA 510(k)

Creatine Kinase-MB

K-Number: K162526 · 2017-05-26

ApplicantRoche Diagnostics
Decision Date2017-05-26
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Creatine Kinase-MB is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2017-05-26 under approval number K162526. The device is classified under product code JHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Creatine Kinase-MB?

Creatine Kinase-MB is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by Roche Diagnostics. The 510(k) number is K162526.

When was Creatine Kinase-MB approved by the FDA?

Creatine Kinase-MB received FDA 510(k) clearance on 2017-05-26, under approval number K162526.

What company makes Creatine Kinase-MB?

Creatine Kinase-MB is manufactured by Roche Diagnostics.

What is the FDA product code for Creatine Kinase-MB?

The FDA product code for Creatine Kinase-MB is JHW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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