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FDA 510(k)

RF

K-Number: K990035 · 1999-03-08

ApplicantAbbott Laboratories
Decision Date1999-03-08
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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 1999-03-08 under 510(k) number K990035. 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 RF?

RF is a medical device that received FDA 510(k) clearance on 1999-03-08. The listed applicant is Abbott Laboratories. The 510(k) number is K990035.

When did RF receive FDA 510(k) clearance?

RF received FDA 510(k) clearance on 1999-03-08, under 510(k) number K990035.

Who is the listed applicant for 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 RF?

The FDA product code for RF is DHR.

Related PubMed Literature

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.

PMID: 41693672Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report.Journal of diabetes science and technology ()PMID: 41966145From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".International journal of health policy and management ()PMID: 39420619Polymer-interface-tissue model to estimate leachable release from medical devices.Mathematical medicine and biology : a journal of the IMA ()PMID: 37288633[Roadmap of Medical Device for Implanted Brain-computer Interface].Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation ()

Other records listing Abbott Laboratories 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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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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