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FDA 510(k)

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS

K-Number: K161854 · 2016-10-04

ApplicantThe Binding Site Group , Ltd.
Decision Date2016-10-04
Product CodePCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS is a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2016-10-04 under approval number K161854. The device is classified under product code PCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS?

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS is a medical device that received FDA 510(k) clearance on 2016-10-04. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K161854.

When was Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS approved by the FDA?

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS received FDA 510(k) clearance on 2016-10-04, under approval number K161854.

What company makes Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS?

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS is manufactured by The Binding Site Group , Ltd..

What is the FDA product code for Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS?

The FDA product code for Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS is PCN.

Other Devices by The Binding Site Group , Ltd.

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Related Devices (Code: PCN)

K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda 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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