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FDA 510(k)

EUROGENETICS CRP ELISA

K-Number: K872539 · 1987-10-20

ApplicantEurogenetics
Decision Date1987-10-20
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROGENETICS CRP ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Eurogenetics. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K872539. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROGENETICS CRP ELISA?

EUROGENETICS CRP ELISA is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Eurogenetics. The 510(k) number is K872539.

When did EUROGENETICS CRP ELISA receive FDA 510(k) clearance?

EUROGENETICS CRP ELISA received FDA 510(k) clearance on 1987-10-20, under 510(k) number K872539.

Who is the listed applicant for EUROGENETICS CRP ELISA?

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

What is the FDA product code for EUROGENETICS CRP ELISA?

The FDA product code for EUROGENETICS CRP ELISA is DCN.

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Related Devices (Code: DCN)

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

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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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