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FDA 510(k)

Rheumatoid Factor (RF) Kit for use on SPAPLUS

K-Number: K160070 · 2016-12-07

ApplicantThe Binding Site Group , Ltd.
Decision Date2016-12-07
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Rheumatoid Factor (RF) Kit for use on SPAPLUS is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2016-12-07 under 510(k) number K160070. 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) Kit for use on SPAPLUS?

Rheumatoid Factor (RF) Kit for use on SPAPLUS is a medical device that received FDA 510(k) clearance on 2016-12-07. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K160070.

When did Rheumatoid Factor (RF) Kit for use on SPAPLUS receive FDA 510(k) clearance?

Rheumatoid Factor (RF) Kit for use on SPAPLUS received FDA 510(k) clearance on 2016-12-07, under 510(k) number K160070.

Who is the listed applicant for Rheumatoid Factor (RF) Kit for use on SPAPLUS?

The FDA 510(k) record lists The Binding Site Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rheumatoid Factor (RF) Kit for use on SPAPLUS?

The FDA product code for Rheumatoid Factor (RF) Kit for use on SPAPLUS is DHR.

Other records listing The Binding Site Group , Ltd. 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.

K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserK250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitK192116Human IgA liquid reagent kit for Use on SPAPlusK191985Optilite IgA KitK191635Optilite IgM KitK191465Human IgM Kit for use on SPAPlus

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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.

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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