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FDA 510(k)

RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

K-Number: K102673 · 2011-09-30

ApplicantPhadia US, Inc.
Decision Date2011-09-30
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Phadia US, Inc.. It received FDA 510(k) clearance on 2011-09-30 under 510(k) number K102673. 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 RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM?

RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-30. The listed applicant is Phadia US, Inc.. The 510(k) number is K102673.

When did RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM receive FDA 510(k) clearance?

RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM received FDA 510(k) clearance on 2011-09-30, under 510(k) number K102673.

Who is the listed applicant for RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM?

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

What is the FDA product code for RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM?

The FDA product code for RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM is DHR.

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Other records listing Phadia US, Inc. 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.

K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYK122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESK113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLEK112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYK111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSK093459ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01

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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.K100499ORGENTEC RHEUMATOID FACTOR EIAOrgentec Diagnostika GmbH

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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