FDA 510(k)

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit

K-Number: K172613 · 2018-02-15

Decision Date2018-02-15

Product CodePCN

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit 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 2018-02-15 under 510(k) number K172613. 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 Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit?

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit is a medical device that received FDA 510(k) clearance on 2018-02-15. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K172613.

When did Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit receive FDA 510(k) clearance?

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit received FDA 510(k) clearance on 2018-02-15, under 510(k) number K172613.

Who is the listed applicant for Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit?

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 Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit?

The FDA product code for Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit is PCN.

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 Analyser K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit K192116Human IgA liquid reagent kit for Use on SPAPlus K191985Optilite IgA Kit K191635Optilite IgM Kit K191465Human IgM Kit for use on SPAPlus

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Related Devices (Code: PCN)

K161854Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUSThe Binding Site Group , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.