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FDA 510(k)

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

K-Number: K160915 · 2016-12-14

ApplicantRoche Diagnostics
Decision Date2016-12-14
Product CodeOVK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2016-12-14 under approval number K160915. The device is classified under product code OVK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker?

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker is a medical device that received FDA 510(k) clearance on 2016-12-14. It is manufactured by Roche Diagnostics. The 510(k) number is K160915.

When was Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker approved by the FDA?

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker received FDA 510(k) clearance on 2016-12-14, under approval number K160915.

What company makes Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker?

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker?

The FDA product code for Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker is OVK.

Related Clinical Trials

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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.

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