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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 a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2016-12-07 under approval 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. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K160070.

When was Rheumatoid Factor (RF) Kit for use on SPAPLUS approved by the FDA?

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

What company makes Rheumatoid Factor (RF) Kit for use on SPAPLUS?

Rheumatoid Factor (RF) Kit for use on SPAPLUS is manufactured by The Binding Site Group , Ltd..

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 Devices by The Binding Site Group , Ltd.

K161854Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS K153560Optilite Low Level Albumin Kit K160819Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit K162263Optilite Rheumatoid Factor Kit K180099Optilite High Sensitivity C-Reactive Protein Kit K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit

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Related Devices (Code: DHR)

K162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd. K182747EliA RF IgM ImmunoassayPhadia AB K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc. K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical Company

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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