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FDA 510(k)

CYFRA 21-1 EIA MODEL 211-10

K-Number: K100831 · 2011-05-26

ApplicantFujirebio Diagnostics,Inc.
Decision Date2011-05-26
Product CodeOVK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CYFRA 21-1 EIA MODEL 211-10 is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2011-05-26 under 510(k) number K100831. 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 CYFRA 21-1 EIA MODEL 211-10?

CYFRA 21-1 EIA MODEL 211-10 is a medical device that received FDA 510(k) clearance on 2011-05-26. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K100831.

When did CYFRA 21-1 EIA MODEL 211-10 receive FDA 510(k) clearance?

CYFRA 21-1 EIA MODEL 211-10 received FDA 510(k) clearance on 2011-05-26, under 510(k) number K100831.

Who is the listed applicant for CYFRA 21-1 EIA MODEL 211-10?

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

What is the FDA product code for CYFRA 21-1 EIA MODEL 211-10?

The FDA product code for CYFRA 21-1 EIA MODEL 211-10 is OVK.

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Related Devices (Code: OVK)

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.

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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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