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FDA 510(k)

RHEUMATOID FACTOR (RF)

K-Number: K024067 · 2003-01-15

ApplicantAbbott Laboratories
Decision Date2003-01-15
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMATOID FACTOR (RF) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2003-01-15 under 510(k) number K024067. 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 (RF)?

RHEUMATOID FACTOR (RF) is a medical device that received FDA 510(k) clearance on 2003-01-15. The listed applicant is Abbott Laboratories. The 510(k) number is K024067.

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

RHEUMATOID FACTOR (RF) received FDA 510(k) clearance on 2003-01-15, under 510(k) number K024067.

Who is the listed applicant for RHEUMATOID FACTOR (RF)?

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

What is the FDA product code for RHEUMATOID FACTOR (RF)?

The FDA product code for RHEUMATOID FACTOR (RF) is DHR.

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Other records listing Abbott Laboratories as applicant

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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.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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