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FDA 510(k)

Optilite IgM Kit

K-Number: K191635 · 2019-07-15

ApplicantThe Binding Site Group , Ltd.
Decision Date2019-07-15
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite IgM Kit is a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2019-07-15 under approval number K191635. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optilite IgM Kit?

Optilite IgM Kit is a medical device that received FDA 510(k) clearance on 2019-07-15. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K191635.

When was Optilite IgM Kit approved by the FDA?

Optilite IgM Kit received FDA 510(k) clearance on 2019-07-15, under approval number K191635.

What company makes Optilite IgM Kit?

Optilite IgM Kit is manufactured by The Binding Site Group , Ltd..

What is the FDA product code for Optilite IgM Kit?

The FDA product code for Optilite IgM Kit is CFN.

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: CFN)

K162208DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc. K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group , Ltd. K191985Optilite IgA KitThe Binding Site Group , Ltd. K191465Human IgM Kit for use on SPAPlusThe Binding Site Group , Ltd. K190686Optilite IgM CSF KitThe Binding Site Group , Ltd. K183151Optilite IgA CSF 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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