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FDA 510(k)

Optilite Rheumatoid Factor Kit

K-Number: K162263 · 2017-05-03

ApplicantThe Binding Site Group , Ltd.
Decision Date2017-05-03
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite Rheumatoid Factor Kit is a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2017-05-03 under approval number K162263. 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 Optilite Rheumatoid Factor Kit?

Optilite Rheumatoid Factor Kit is a medical device that received FDA 510(k) clearance on 2017-05-03. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K162263.

When was Optilite Rheumatoid Factor Kit approved by the FDA?

Optilite Rheumatoid Factor Kit received FDA 510(k) clearance on 2017-05-03, under approval number K162263.

What company makes Optilite Rheumatoid Factor Kit?

Optilite Rheumatoid Factor Kit is manufactured by The Binding Site Group , Ltd..

What is the FDA product code for Optilite Rheumatoid Factor Kit?

The FDA product code for Optilite Rheumatoid Factor Kit is DHR.

Other Devices by The Binding Site Group , Ltd.

K160070Rheumatoid Factor (RF) Kit for use on SPAPLUS 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 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)

K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe 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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