FDA 510(k)

Creatine Kinase-MB

K-Number: K162526 · 2017-05-26

Decision Date2017-05-26

Product CodeJHW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Creatine Kinase-MB is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2017-05-26 under 510(k) 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. The listed applicant is Roche Diagnostics. The 510(k) number is K162526.

When did Creatine Kinase-MB receive FDA 510(k) clearance?

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

Who is the listed applicant for Creatine Kinase-MB?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Roche Diagnostics as applicant

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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.