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FDA 510(k)

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

K-Number: K160819 · 2016-06-16

ApplicantThe Binding Site Group , Ltd.
Decision Date2016-06-16
Product CodeOPX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit is a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2016-06-16 under approval number K160819. The device is classified under product code OPX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit?

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit is a medical device that received FDA 510(k) clearance on 2016-06-16. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K160819.

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

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit received FDA 510(k) clearance on 2016-06-16, under approval number K160819.

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

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

What is the FDA product code for Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit?

The FDA product code for Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit is OPX.

Other Devices by The Binding Site Group , Ltd.

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View all 17 devices →

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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