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FDA 510(k)

ANTI-MUTATED CITRULLINATED VIMENTIN EIA

K-Number: K092399 · 2010-07-01

ApplicantOrgentec Diagnostika GmbH
Decision Date2010-07-01
Product CodeOQZ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-MUTATED CITRULLINATED VIMENTIN EIA is the device name listed in this FDA 510(k) record. The listed applicant is Orgentec Diagnostika GmbH. It received FDA 510(k) clearance on 2010-07-01 under 510(k) number K092399. The device is classified under product code OQZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-MUTATED CITRULLINATED VIMENTIN EIA?

ANTI-MUTATED CITRULLINATED VIMENTIN EIA is a medical device that received FDA 510(k) clearance on 2010-07-01. The listed applicant is Orgentec Diagnostika GmbH. The 510(k) number is K092399.

When did ANTI-MUTATED CITRULLINATED VIMENTIN EIA receive FDA 510(k) clearance?

ANTI-MUTATED CITRULLINATED VIMENTIN EIA received FDA 510(k) clearance on 2010-07-01, under 510(k) number K092399.

Who is the listed applicant for ANTI-MUTATED CITRULLINATED VIMENTIN EIA?

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

What is the FDA product code for ANTI-MUTATED CITRULLINATED VIMENTIN EIA?

The FDA product code for ANTI-MUTATED CITRULLINATED VIMENTIN EIA is OQZ.

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Other records listing Orgentec Diagnostika GmbH as applicant

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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