FDA 510(k)

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

K-Nummer: K161854 · 2016-10-04

AntragstellerThe Binding Site Group , Ltd.

Entscheidungsdatum2016-10-04

ProduktcodePCN

BeratungsausschussIM

EntscheidungSubstantially Equivalent

Produktübersicht

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

Häufig gestellte Fragen

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. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K161854.

When did Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS receive FDA 510(k) clearance?

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 510(k) number K161854.

Who is the listed applicant for Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the 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 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.

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Weitere Einträge mit The Binding Site Group , Ltd. als Antragsteller

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Verwandte Geräte (Code: PCN)

K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group , Ltd.

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