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FDA 510(k)

ORGENTEC RHEUMATOID FACTOR EIA

K-Number: K100499 · 2010-10-27

ApplicantOrgentec Diagnostika GmbH
Decision Date2010-10-27
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORGENTEC RHEUMATOID FACTOR 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 2010-10-27 under 510(k) number K100499. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORGENTEC RHEUMATOID FACTOR EIA?

ORGENTEC RHEUMATOID FACTOR EIA is a medical device that received FDA 510(k) clearance on 2010-10-27. The listed applicant is Orgentec Diagnostika GmbH. The 510(k) number is K100499.

When did ORGENTEC RHEUMATOID FACTOR EIA receive FDA 510(k) clearance?

ORGENTEC RHEUMATOID FACTOR EIA received FDA 510(k) clearance on 2010-10-27, under 510(k) number K100499.

Who is the listed applicant for ORGENTEC RHEUMATOID FACTOR 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 ORGENTEC RHEUMATOID FACTOR EIA?

The FDA product code for ORGENTEC RHEUMATOID FACTOR EIA is DHR.

Related Clinical Trials

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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.

K092399ANTI-MUTATED CITRULLINATED VIMENTIN EIAK030929ANA DETECT

Related Devices (Code: DHR)

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.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.

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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