Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit

K-Number: K172613 · 2018-02-15

ApplicantThe Binding Site Group , Ltd.
Decision Date2018-02-15
Product CodePCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit is a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2018-02-15 under approval 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. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K172613.

When was Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit approved by the FDA?

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

What company makes Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit?

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit is manufactured by The Binding Site Group , Ltd..

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 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 K162263Optilite Rheumatoid Factor Kit K180099Optilite High Sensitivity C-Reactive Protein Kit

View all 17 devices →

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

View on FDA Database →

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

↑