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FDA 510(k)

Elecsys CYFRA 21-1 CalCheck 5

K-Number: K162173 · 2017-01-12

ApplicantRoche Diagnostics
Decision Date2017-01-12
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys CYFRA 21-1 CalCheck 5 is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2017-01-12 under approval number K162173. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys CYFRA 21-1 CalCheck 5?

Elecsys CYFRA 21-1 CalCheck 5 is a medical device that received FDA 510(k) clearance on 2017-01-12. It is manufactured by Roche Diagnostics. The 510(k) number is K162173.

When was Elecsys CYFRA 21-1 CalCheck 5 approved by the FDA?

Elecsys CYFRA 21-1 CalCheck 5 received FDA 510(k) clearance on 2017-01-12, under approval number K162173.

What company makes Elecsys CYFRA 21-1 CalCheck 5?

Elecsys CYFRA 21-1 CalCheck 5 is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys CYFRA 21-1 CalCheck 5?

The FDA product code for Elecsys CYFRA 21-1 CalCheck 5 is JJX.

Other Devices by Roche Diagnostics

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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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